FDA recall, Mar 20, 2026, Moderate risk

I.T.S. Orthopedic Plates and Screws

Volar Radius Plate with Angular Stability may cause higher temperature increases under certain MRI conditions.

Summary by Recall Canary from the FDA notice

I.T.S. GmbH of Lasnitzhohe, Austria, began the recall on January 23, 2026, for the Foot Locking Plates System, Olecranonplate with Angular Stability, Headless Compression Screw System, Distal Humeral Plates with Angular Stability, Hand Locking Plates System, I.T.S. Straight Plate with Angular Stability, I.T.S. Pelvic Reconstruction System, I.T.S. Screw System, and other products, after updated MRI safety testing demonstrated higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use.

The FDA added the recall to its Enforcement Report on March 20, 2026, with distribution nationwide in multiple states.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

Product details
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw;
Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw;
Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw;
Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved;
Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape;
Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape;
Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight;
Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw;
Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate;
Article Numbers: 21015-08, 21015-09.
Lot code
37303-10
151720
268729
679
032432
072268
102237
102307
37303-12
570637
032434
072269
102346
112227
37303-14
751091
F66913
012510
062288
102359
112410
37303-16
072263
102245
151841
F66914
331193
543625
012511
042403
102360
37303-18
210467
231415
341194
572633
771093
012512
022507
042404
102248
112319
37303-20
211468
351195
573634
701585
781094
022508
042420
All 271
112216
112328
37303-22
171705
212469
361196
574635
791095
022509
042417
112224
112340
37303-24
575639
741572
F66915
022510
112226
122313
122333
37303-26
152346
214471
F66916
012403
112230
122323
37303-28
F66917
112231
122328
37303-30
192716
591743
122334
32271-10
231167
062351
32271-12
048927
F66235
042215
062342
062405
062489
072271
32271-14
049928
231165
F66140
042210
052340
052518
062471
062490
072267
32271-16
231164
311125
F66141
042216
052519
062315
062483
072272
072401
32271-18
062950
F65556
F66236
032261
062332
072402
32271-20
063951
F66237
052326
32271-22
064952
F65557
032263
062354
32271-24
065953
F65558
062333
32271-26
032265
32271-28
F65559
062357
052520
32271-32
F65561
32271-34
F65562
37304-10
635486
F24799
012419
011176
37304-12
061352
521172
5211721
576643
630487
012433
092207
122409
37304-14
081360
531173
5311731
577644
631488
012434
092208
122410
37304-16
541174
578645
632489
012444
092201
122411
37304-18
551175
633490
022403
092202
37304-20
011320
561176
634491
012287
012420
082217
483331
37304-22
241273
012288
012421
37304-24
021321
571177
012289
012445
21413-6
F52124
21431-ME
102045
21482
092020
21483
F55902
21421-5
F65377
092039
37241-10
012169
610104
701013
37241-12
231295
767108
37241-14
511016
537392
F24807
012280
37241-16
005340
121106
231387
521017
560517
37241-18
232328
531018
072408
311848
37241-20
233388
541020
562519
072419
287847
37241-22
066109
234389
551021
F24594
F24811
37241-24
561022
564521
608110
F24595
37241-26
611111
711023
F24596
F24813
37241-28
612112
721024
811597
F24597
485508
37241-30
015172
613113
731019
F24598
21015-08
0123-12
0321-43
0723-07
21015-09
0123-13
Product details
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate;
Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate;
Article Numbers: 21111-6, 21111-8, 21111-12.
Lot code
21112-7
643
0549
21114-5
032301
042303
042304
0618
102211
112304
21113-9
072320
21111-6
032306
072319
112201
21111-8
032318
21111-12
032305
Product details
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated;
Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
Lot code
31207-10
679
112002
31207-12
092133
102343
112006
31207-14
102050
31207-16
102345
102049
31207-18
0323110
102355
112001
31207-20
0323111
102051
102356
31207-24
102028
31207-26
112008
31207-28
112009
31207-30
0323140
483377
31257-12
081904
31257-14
042323
081905
31257-16
042324
31257-18
112308
022128
31257-20
022123
042326
112321
31257-22
022124
042327
112325
31257-24
022125
112326
All 88
31257-28
022130
052306
31257-30
022131
31307-18
061907
31307-32
062285
31307-34
062286
31307-36
062287
31307-38
032118
31358-30
F67790
31437-30
071916
31437-38
071918
31437-40
032406
071903
31437-50
071920
31757-100
51892
31757-120
320792
31757-45
320793
31757-80
F55872
31757-85
F55873
31757-90
F55874
Product details
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking;
Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal;
Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
Lot code
37351-10-N
240314
679
122205
37351-12-N
200330
943977
F65544
032401
052417
122261
37351-14-N
201331
511504
944978
F65545
032402
032514
052244
052418
052516
072520
37351-16-N
202332
521505
945979
F65163
032423
032504
052201
062466
062504
072521
122251
37351-18-N
203333
531506
946980
971215
F65546
022329
022516
032430
062206
062505
072522
37351-20-N
231334
541507
952981
All 171
F65164
F65547
032431
062230
072501
122202
37351-22-N
233335
953982
F65548
062233
092111
122210
37351-24-N
238336
956983
F65549
042415
072203
112242
37351-26-N
204337
947984
F65166
F65550
022330
042416
062207
37351-28-N
234338
954985
F65551
022331
042423
072204
37351-30-N
205339
948986
F65552
042424
072205
122209
37351-32-N
235340
955987
F65553
042425
062234
37351-34-N
206341
491108
F65554
012306
042426
062208
37351-36-N
239342
571109
571503
F65555
022324
052401
062209
37351-38-N
230679
501110
862696
052402
122252
37351-40-N
147
15088L
207343
506128
511111
052411
37351-42-N
581112
032515
37351-44-N
591113
022511
37351-46-N
601114
37351-48-N
611115
032517
37351-50-N
513248
621116
912703
032518
062508
37351-55-N
652407
032519
37351-60-N
662408
37351-65-N
022512
052236
37351-70-N
631117
052237
37351-75-N
641118
052238
37351-80-N
052239
072406
37351-85-N
052240
21241-5
770
201905
21241-7
201906
21242-7
201901
21243-10
21244-9
Product details
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw;
Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape;
Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape;
Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square;
Article Numbers: 21517. 5. HLS Plate, Straight;
Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape;
Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw;
Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
Lot code
32151-6
408462
500495
691266
32151-8
408866
531370
32151-9
351668
541373
741269
32151-10
408986
551374
32151-11
371670
561375
32151-12
409087
571376
771272
32151-13
581377
32151-14
409289
591378
791274
32151-15
409390
32151-16
409491
32151-18
821277
32151-20
831278
21505-4
350493
677353
21506-4
642718
677157
21507-4
F65050
21508-4
F63934
677180
21517
F66911
21502
677136
All 116
21503-4
337934
21503-6
868870
21503-8
F63936
21503-10
337896
677146
21504-6
F63364
868885
21504-8
F63365
21504-10
642711
677154
21513-3
677385
21513-5
677389
21514-3
F63935
21514-5
642722
677183
869183
37151-5
561228
37151-8
166019
37151-9
625633
37151-10
626634
37151-12
628636
671232
37151-13
166423
37151-15
206189
37151-16
691234
37151-18
37151-24
167068
37251-8
421197
37251-9
591223
37251-11
619644
37251-12
620645
37251-13
521703
37251-14
531704
951141
37251-16
623648
971143
37251-20
571708
F61731
Product details
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved;
Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight;
Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate;
Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm;
Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm;
Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm;
Article Number: 21102-6. 7. Straight Plate, 4.5mm;
Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.
Lot code
21604-6
643
052301
0652
092201
21604-9
032311
062308
062309
112310
122201
21605-11
072314
102207
21605-6
0654
072306
072316
072338
102208
102212
102217
112306
122202
21605-9
0643
0662
072307
072339
112309
122203
21105-6
876787
21105-8
876788
21104-4
679
052234
082305
036334
21104-5
0722101
082306
036335
21104-6
012307
876760
21104-7
082307
036336
All 96
876781
21104-8
082308
876783
21104-9
876904
21101-5
876637
21101-6
121605
1105-12
F41923
876638
903610
21101-7
770
201905
0518-06
042303
876640
21101-8
876721
062224
21101-9
122264
876727
21101-11
876633
21101-13
876635
21102-6
21103-8
092216
21103-9
062215
876758
21103-10
092219
876741
21103-11
062214
21103-12
876743
21103-13
022303
876745
Product details
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate;
Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate;
Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate;
Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw;
Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking;
Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous;
Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw;
Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking;
Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90. 9. Curved Plate;
Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20. 10. Posterior Column Plate, Left;
Article Numbers: 212121-6. 11. Posterior Column Plate, Right;
Article Numbers: 212131-6. 12. Posterior Wall Plate, Extended, Left;
Article Numbers: 212101-SM. 13. Posterior Wall Plate, Extended, Left;
Article Numbers: 212101-LA. 14. Posterior Wall Plate, Extended, Right;
Article Numbers: 212111-LA, 212111-SM. 15. Posterior Wall Plate, Left;
Article Numbers: 212141-7, 212141-8. 16. Posterior Wall Plate, Right;
Article Numbers: 212151-7, 212151-8. 17. PRS Plate;
Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7. 18. Quadrilateral Buttress Plate;
Article Numbers: 21208-13, 21209-13. 19. Quadrilateral Buttress Plate;
Article Numbers: 21208-11, 21209-11. 20. Rim Plate, Left;
Article
Lot code
21218-16
679
112166
122229
122230
122304
21219-16
012441
062456
0624561
112167
122228
21218-14
032417
102231
112158
112164
122231
21219-14
012505
112159
112165
122227
122305
21216-10
032501
062453
072276
072510
092203
092401
112168
112409
122270
21216-12
032503
062344
062454
072277
092204
112170
112413
122271
21217-10
032502
062346
072278
092402
092404
102216
All 1428
112169
112423
21217-12
022238
062345
072513
092403
112171
122407
122426
30591-36
30591-70
231539
775273
30591-75
751307
30591-80
777295
30591-85
301308
30591-90
311309
37422-12-N
145897
461842
37422-14-N
215281
032001
062320
092355
122326
37422-16-N
052229
052307
102214
102306
122329
37422-18-N
240520
452529
473354
052316
102215
102337
122330
37422-20-N
0323147
072306
102211
102338
122331
37422-22-N
092876
543636
012406
062361
072312
102212
102348
37422-24-N
012407
052333
072313
102349
37422-26-N
012435
062316
072322
102353
37422-28-N
192499
012422
032211
062317
062323
072323
102361
37422-30-N
217289
012436
032212
0323142
072324
102354
37422-32-N
218290
012437
052335
052337
072329
112306
37422-34-N
031830
219291
012446
062337
062341
072330
112318
37422-36-N
220292
240540
734742
012447
042317
042321
062003
072334
37422-38-N
105881
221293
362296
412482
012243
022407
052331
052334
072349
112323
37422-40-N
052830
222294
240538
493069
736744
022401
032310
042302
072354
112329
37422-42-N
053831
081544
223295
364298
733745
022402
062371
082304
112330
37422-44-N
054832
224296
365299
737746
781832
022412
042331
042345
082314
112335
37422-46-N
052578
225314
366300
738747
022419
042313
042318
082319
112336
37422-48-N
056834
226315
022423
052324
052328
072316
092314
112337
37422-50-N
227316
740748
022436
042336
052314
092342
112338
37422-55-N
113882
368302
032215
052336
062309
092322
112324
37422-60-N
229318
240517
927095
33034
032403
062349
062351
092325
122307
37422-65-N
118884
230319
271754
743749
761192
35846
032216
072303
092326
122308
37422-70-N
102213
744750
893916
062368
092338
122309
37422-75-N
122888
231839
072304
122306
37422-80-N
122254
124887
062352
122320
37422-85-N
056936
271837
012256
092339
37422-90-N
050600
321273
092340
37422-95-N
130891
092341
37422-100-N
132892
341607
102403
37422-105-N
102404
37422-110-N
136894
371843
092337
37422-115-N
138895
391845
012262
37422-120-N
140896
092349
37592-18
072351
37592-20
831792
252862
37592-22
172773
072356
37592-24
082301
37592-26
182774
082303
37592-28
012140
082310
37592-30
112775
082317
37592-32
082312
37592-34
192863
082313
37592-36
082318
37592-38
092308
37592-40
052116
072314
37592-42
092310
37592-46
092772
092312
37592-48
052118
092313
37592-50
092343
37592-54
072315
37592-56
721587
37592-58
092334
37592-60
042213
072325
092345
37592-65
072331
37592-70
042289
072340
092353
37592-75
429442
092351
37592-80
052204
072341
092335
37592-85
042291
072342
092354
37592-90
042292
092352
31851-60
373463
813133
31851-65
374464
31851-70
375465
31851-75
376467
31851-80
125212
377468
431563
867967
31851-85
044945
378469
441564
31851-90
045946
343266
451565
31851-95
046947
128224
379470
461566
31851-100
129225
471567
821469
860968
31851-105
380471
31851-110
901298
387472
31851-115
381473
048949
31851-120
049950
133227
511577
862970
31851-125
050951
347474
521578
31851-130
344368
531579
31851-135
382475
541580
31851-140
052953
551777
863971
31851-145
054954
137229
345351
561779
31851-150
138260
191042
346352
571780
797898
31851-155
201043
384476
31851-160
062955
799900
866972
31851-165
063956
211045
385477
31851-170
141230
221046
348353
31851-175
064957
142263
386398
31851-180
065958
143264
388399
31851-185
389400
31851-190
066959
390401
31851-195
067960
391478
31851-200
013266
392479
31854-60
393482
31854-65
394499
691605
31854-70
070983
395500
31854-75
396501
31854-80
072985
397502
731608
31854-85
149247
240529
741609
872961
31854-90
150280
398503
751610
873962
31854-95
399504
761611
874963
31854-100
400505
771612
868964
31854-105
401506
31854-110
073986
869965
31854-115
074987
402507
801615
31854-120
403508
870966
31854-125
404509
821617
31854-130
075988
405366
831618
31854-135
076989
406510
31854-140
407369
851693
31854-145
408370
861706
31854-150
160285
409371
871704
31854-155
410511
31854-160
1622951
411372
862761
891708
31854-165
163286
412512
31854-170
164296
413513
31854-175
079992
414514
31854-180
080993
415515
31854-185
416373
808929
31854-190
082995
31854-195
083996
961715
31854-200
084997
417516
32351-10
019937
208200
731287
052205
122249
32351-12
020938
209211
741316
062203
102243
32351-14
210212
501230
761312
012324
032524
042419
062225
082501
122207
32351-16
022940
211212
771313
022311
022533
032525
042421
072201
092501
122204
32351-18
212213
781322
801041
022312
032526
042427
072202
102501
122208
32351-20
024942
213214
791323
032527
042428
102502
112225
32351-22
025943
214215
801324
8013241
821061
052219
112235
32351-24
026988
215216
811325
8113251
831062
052206
102239
32351-26
027989
216217
821326
841063
052202
052407
112236
32351-28
028990
217218
8313271
052220
102235
32351-30
029991
218219
841314
062205
122260
32351-32
219220
301035
851315
8513151
012303
052203
32351-34
220221
311041
861328
961089
052243
112229
32351-36
230222
411090
052221
112241
32351-38
131369
1313691
221226
321091
F66144
052207
102247
32351-40
222223
331092
052208
122243
32351-42
223224
341093
871329
8713291
112214
32351-44
351094
881330
8813301
921138
052209
112211
32351-46
225227
361095
891331
8913311
931313
042217
112215
32351-48
226228
371096
052210
122244
32351-50
227229
381097
941314
012304
052211
32351-55
391098
901332
951142
951315
042218
112237
32351-60
229231
401099
961316
042283
122250
32351-65
981144
022326
042284
32351-70
236233
32351-75
237234
022328
32351-80
461103
042286
32351-85
431104
32352-16
022406
072207
122427
32352-18
012501
022344
052182
32352-20
670753
012453
012504
022345
052184
052311
32352-22
237340
012454
022346
022506
062101
072208
122003
32352-24
238437
672755
022404
032379
032528
052312
062102
072209
122424
32352-26
239357
673756
022352
022405
032512
052313
072210
122416
32352-28
240358
674757
022411
032267
032324
032529
052303
072211
122418
32352-30
675758
950241
022417
022513
032325
052304
072213
102414
102513
32352-32
242360
676759
022418
032323
032530
052305
072214
122421
32352-34
243361
677760
022426
022514
032326
052301
072280
102401
32352-36
244362
678761
032327
032531
042274
052302
072282
122422
32352-38
245363
679762
022428
0323112
032392
032513
072283
112502
122413
32352-40
246364
680763
012506
022438
032268
032375
042342
072112
072285
112505
122419
32352-42
247365
681764
012507
012508
032347
042343
062246
32352-44
248366
682765
012217
012503
032339
062247
32352-46
249367
683766
819818
012218
022526
032371
042332
062249
072294
102402
122501
32352-48
250368
022444
022505
032372
062251
102180
32352-50
251369
685768
012509
022452
032364
042329
062253
072295
112434
32352-55
252370
686769
022504
032376
062255
072296
072297
122401
122504
32352-60
253438
687770
012222
022527
032328
062257
072298
32352-65
254460
688798
022457
022520
032343
062259
32352-70
255371
823821
032344
032408
042316
062261
082201
32352-75
256429
022522
032398
032399
032409
062263
32352-80
257430
022523
0323104
0323107
032410
062265
32352-85
0323109
0323113
062267
32352-90
0323138
0323141
062268
32352-95
0323146
0323148
062271
32352-100
012230
032266
032411
042301
062273
32352-105
032412
032509
042311
062275
32352-110
032413
032521
042312
062277
32352-115
032418
042319
062279
32352-120
032419
042320
062281
32455-18
371232
32455-20
892124
32455-22
391234
434375
032395
32455-24
401235
435376
F62579
032387
032396
092502
32455-26
411236
436377
032397
092503
32455-28
437378
032345
32455-30
256241
032346
032388
32455-32
438380
441239
F62581
032384
32455-34
440381
451240
565613
F62918
032385
32455-36
441382
461241
F62582
032389
32455-38
442383
471242
022353
032363
092507
32455-40
481243
4812431
F62583
26F
62583
022351
032349
32455-42
491244
F62584
32455-44
445386
501245
022354
032366
32455-46
511246
F62585
032317
032367
32455-48
231444
446387
022355
032368
32455-50
531248
32455-52
541249
032318
032369
32455-54
377660
392952
551250
32455-56
032373
32455-58
378662
412953
571252
32455-60
032319
032374
32455-65
591254
32455-70
601255
F62586
32455-75
611256
32455-80
621257
F62587
32455-85
231516
F62588
32455-90
641259
0323108
32475-32
F16726
37455-18
231558
37455-20
021319
37455-22
211320
37455-24
671425
37455-26
221322
231449
37455-28
041323
37455-30
231324
37455-32
051325
37455-34
241326
37455-36
061375
F62605
37455-38
251376
37455-40
532513
691442
F62606
37455-42
151343
261380
37455-44
081388
37455-46
231515
37455-48
231514
37455-50
281394
37455-52
101395
37455-54
701444
37455-56
111408
656368
37455-60
121449
572515
37455-65
131479
37455-70
141480
F62607
37455-75
151481
F62608
37455-80
686476
F62609
37455-85
171483
F62610
37455-90
181484
211911-4
0825-10
012425
022531
0323131
062430
0624301
102431
122267
211911-5
0724-28
1225-04
012426
022321
022518
0323132
052527
0624311
0624312
102432
211911-6
1024-15
012427
022322
022501
042513
062432
0624322
102433
112177
211911-7
0724-31
0724-32
0724-33
0724-34
0724-35
0725-16
1225-05
022323
022502
052529
062231
102434
211911-8
012428
022503
022532
0323135
112178
112407
211911-10
0724-39
1024-17
0323127
102429
112179
122266
211911-12
0323128
102228
112203
112219
211911-14
0323129
102229
112221
211911-16
0323130
062232
112222
211911-20
062429
112418
122268
212121-6
052152
062338
122235
212131-6
062319
122234
212101-SM
042515
052322
122215
122303
122402
212101-LA
0724-48
1024-09
062313
062443
112206
122302
122405
212111-LA
032421
042516
062347
062402
062445
122414
212111-SM
0724-65
1024-10
1024-11
022530
032246
062318
062403
062473
092237
112015
122406
212141-7
0724-81
0724-85
032331
052168
062448
122214
212141-8
022408
032332
052429
062449
0624491
062474
122233
212151-7
0624-06
012449
052153
062219
062450
062475
102230
112239
212151-8
0624-11
0724-51
012450
032248
062451
072508
21194-6
042247
21194-7
042249
21194-8
042250
21195-10
042252
21195-12
042253
21195-7
032221
21208-13
032414
052428
062122
102435
112162
112174
122221
122222
21209-13
062442
0624421
112163
112175
112408
122236
21208-11
012429
062440
0624401
112160
112172
122219
21209-11
062441
112161
112173
112412
122237
122238
122239
212061-10
0724-110
062311
112217
122218
212061-14
0724-42
0724-47
032238
032337
062312
212071-10
032415
052329
212071-14
032338
032416
211751-5
052320
112180
112202
112220
211771-4
052321
102227
122301
211821-10
012423
032333
062426
112176
211821-11
0724-71
0724-74
032334
211821-12
022320
211821-14
012424
122217
21161-4
092320
112201
21161-6
032305
032306
042304
052506
062218
211621-4
0724-18
0724-63
042305
062423
102226
112414
211621-6
0825-13
022529
042306
062424
112415
211631-6
0125-35
022515
032315
062302
062425
0624251
112411
211631-8
0724-118
1220-11
062303
122216
Product details
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated;
Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated;
Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer;
Article Number: 36851. 4. Washer, Concave;
Article Numbers: 36432, 36653, 36732. 5. Washer, Flat;
Article Numbers: 36431, 36651, 36653, 36731.
Lot code
31404-16
679
062339
122213
122332
31404-18
122212
062340
31404-20
089221
062343
122241
31404-22
061535
012416
062350
31404-24
071536
062362
122246
31404-26
122245
062363
31404-28
186278
062364
31404-30
187299
012401
062365
122242
31404-32
111540
062366
122211
31404-34
122206
121544
012402
042414
072302
31404-36
188300
052403
072305
112223
31404-38
189301
112213
012455
All 411
072309
31404-40
181043
062321
122201
122310
052404
032532
31404-42
122203
191303
072310
012418
052424
052505
31404-44
192304
112232
052332
052425
052508
31404-46
122240
062322
112210
052426
042505
31404-48
052427
072317
122248
31404-50
194306
112228
062301
122311
052406
052413
042506
062501
31404-55
195307
122258
211647
072326
012452
062467
062511
31404-60
196308
112240
052325
122312
062485
062512
31404-65
122259
072327
205310
022410
31404-70
012301
197309
072328
022413
062479
31404-75
205411
012302
31404-80
172638
205232
321164
022416
31457-30
F50332
31457-36
198343
31457-40
199344
31457-46
947783
736681
31457-50
201346
F67796
31457-55
202347
F67797
31457-60
203355
31652-100
122117
022350
102335
022335
924999
31652-105
022336
032377
31652-110
032380
102339
31652-115
102336
31652-120
092002
102347
31652-25
112134
032340
31652-30
032341
31652-35
082315
31652-40
082316
31652-45
032330
092332
31652-55
032391
092333
31652-60
022337
032378
092336
31652-65
022338
032322
092347
31652-70
032320
032365
042405
112154
31652-75
F65330
032348
032386
31652-80
112181
032321
092350
032362
092348
042410
920995
31652-85
122145
032382
022349
102301
102305
042411
541045
31652-90
012201
032383
022347
042406
31652-95
923998
012202
032316
31731-100
775943
F58803
102420
31731-105
776944
F58804
F65649
102421
31731-110
F58805
F65650
102422
31731-115
F58806
F65651
102423
31731-120
F58807
F65652
102436
31731-50
1244
F14488
F21185
F58793
31731-60
F58795
F65655
31731-65
F65656
F58796
31731-70
F58797
F65657
31731-75
F58798
F65658
31731-80
072040
F58799
F65659
31731-85
331317
F65660
072044
31731-90
1247
1248
F58801
F65661
612
31731-95
581247
F58802
F65662
102437
31732-60
961265
31734-100
F65672
31734-105
F58839
F65673
31734-110
F58840
F65674
032425
31734-115
F65675
31734-120
F58842
F65676
F72277
31734-45
761192
31734-50
F58828
F65680
31734-60
F58830
31734-65
F58831
F65683
032428
31734-70
F58832
F65684
F72275
032429
31734-75
F58833
F65685
31734-80
F58834
F65686
032435
31734-85
F58835
F65687
F72276
31734-90
F65688
032436
31734-95
F58837
F65689
042401
31277-18
F36049
31357-20
091247
31357-22
031707
31357-24
485378
31357-26
121250
31357-28
F65909
31357-30
165201
341054
31357-32
166217
31357-34
167218
31357-36
168219
F65910
31357-38
167220
31357-40
F65911
170221
31357-42
F65912
31357-44
171222
361059
F65913
31357-46
861060
31357-48
172223
F65914
31357-60
F65648
31357-65
012125
31357-70
36851
F59918
F61351
F64885
F64886
F65908
F66506
F71413
F71764
F72364
F73020
F74288
36432
F65379
F67799
F72744
774
300002
36653
F62590
F68455
36732
F67800
36431
F62589
F65378
F66505
F67798
F70092
F72743
F73017
F73494
36651
F61694
F65380
F68454
F73018
F73019
36731
F60987
F62591
F67523
F70093
F72363
F73495
Product details
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate;
Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate;
Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate;
Article Numbers: 21325-4, 21325-7.
Lot code
21301-5
F62569
21301-7
F62570
21301-9
F67518
21301-13
F62568
F67815
21302-5
F67520
21302-7
F67821
21302-9
F62572
F67822
21302-13
F62571
F67519
F67820
21321-7
F54955
F62576
21321-12
F55883
21322-7
F55890
F62578
21322-12
F62577
21325-4
F70528
679
022433
032217
102240
102242
102303
21325-7
102241
102304
Product details
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
Lot code
211341-10
F63368
F65625
F66904
F669041
679
012410
211341-4
F63366
F65626
F656261
F66145
F661451
F66496
F66905
F669051
F73497
012439
022450
211341-7
F63367
F65627
F66146
F66906
012440
21134-4
768
18758
19642
21134-5
778
201904
21135-4
F67801
21382
21136-4
F65629
F66907
F67802
F70071
21383
21136-5
770
101901
21136-7
F65039
F65630
21137-4
F65631
F67804
All 61
21384
21137-7
F65040
21138-4
F65633
F66908
F67806
21139-4
F65634
F67807
21386
Product details
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial;
Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate;
Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm;
Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral;
Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
Lot code
21116-8
679
092230
21117-10
032313
092231
21118-10
032314
072047
092232
21121-6
092236
092329
21121-8
052226
21122-10
0425-02
0825-02
022443
062310
043372
21122-6
0325-01
0425-01
042340
062334
122269
043366
21122-8
0325-08
022243
022304
022451
042209
042214
052319
102368
043368
21123-4
0810-06
052014
062216
21124-4
042333
062217
072346
21127-6
052228
21128-6
042341
Product details
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate;
Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm;
Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate;
Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Lot code
21602-3
643
072330
092310
21602-4
072301
072308
21602-5
022417
0650
072309
21602-6
042305
072333
21602-7
072332
082305
21602-8
0405
012305
21603-3
072331
082306
21603-4
102214
102206
072302
022313
032310
21603-5
072335
122308
21603-6
022309
072305
072311
122309
21603-7
072337
082313
21603-8
072312
122204
21225-4
768
20894
F65041
F66149
679
092305
All 132
022430
F705141
F72362
F73634
21225-6
20895
20039
F65042
F66150
F66499
092321
F705161
062459
F70516
F73635
21225-8
20896
F65635
F66500
F70515
21225-10
F66497
21225-12
F66498
012438
21226-4
F65043
F66152
F66501
F70521
F705211
012412
062306
092306
20897
208978
21226-6
F35433
F65044
F66502
F70522
F705221
062307
092307
20898
21226-8
F66503
012413
20045
20899
21226-10
F66151
21226-12
F66148
012411
21601-5
012302
072323
21601-6
072326
770
201904
21601-7
012303
022308
0647
072315
072327
082303
21601-8
072328
072329
21601-10
022312
082301
082302
21601-12
F70342
21601-14
F70343
21601-16
F70344
Product details
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate;
Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm;
Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small;
Article Numbers: 21093-4, 21093-6.
Lot code
21311-11
F62573
21311-15
F65048
F67521
21311-7
F66165
F67825
21312-11
F65049
F67826
21312-15
F66166
21312-7
F65643
F67827
21094-10
643
032304
082309
21094-4
0572
0571
21094-6
112202
21094-8
012309
3.Article
21093-4
679
032311
112331
21093-6
112332
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Lot code
21064-60
679
012318
0722100
Product details
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate;
Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate;
Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking;
Article Numbers: 37302-18, 37302-20.
Lot code
21232-3
F65636
21232-4
F61722
F65637
21232-6
F62564
F65638
21233-3
F65639
21233-4
F65640
21233-6
F61723
F65046
21234-4
F65641
F66504
21235-4
F65642
F67810
21231-6
643
012301
022310
032308
0630
0657
102402
122301
37302-18
636447
37302-20
802189
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
Lot code
21031-3
679
042207
032240
0323115
052317
F70606
032253
643
032501
072503
102501
21031-5
0015
102201
0323121
0323120
21032-11
112312
21032-3
032241
0623
042293
0323122
062367
052318
022501
062501
072501
102502
21032-5
122136
0323143
042337
21033-3
062212
022301
042338
022302
21033-5
0629
F24901
012311
21034-3
062221
012312
072217
042339
21034-5
102202
All 61
012314
012313
21035-3
062222
042308
012501
0548
21036-3
062213
042309
112317
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
Lot code
70312
F65133
70314
619736

Recall details

Company began the recall

Jan 23, 2026

Sold in

US Nationwide distribution in the states of Alabama, Arizona, BVI, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, USVI, West Virginia, W.

Company

I.T.S. GmbHLasnitzhohe, Austria

Hazard

Device defect

Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID

98341

Recall numbers

Z-1592-2026 to Z-1608-2026

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

Jan 23, 2026
Company began the recall
Mar 20, 2026
Added to FDA's Enforcement Report · Classified by FDA
Apr 1, 2026
In FDA's weekly enforcement report
Apr 23, 2026
Listed on Recall Canary
Oct 3, 2026
Summary updated

What happened

What to do

Is yours affected?

Product details

Product details

Product details

Product details

Product details

Product details

Product details

Product details

Product details

Product details

Product details

Product details

Product details

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

Product details

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

Recall details

Timeline

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