FDA recall, , Moderate risk
Depuy Synthes Attune Revision Hinge Knee Components
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Summary by Recall Canary from the FDA notice
What happened
Depuy Synthes, based in Co. Cork, Ireland, recalled ATTUNE Revision Hinge Knee Hinge Insert Components and Hinge Housing Components because the external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. The recall began May 19, 2026, and was added to the FDA's Enforcement Report on June 29, 2026, affecting Minnesota, North Carolina and Texas.
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.
Incomplete list: 66 of 72 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B;
Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B;
Part Number: 151730412. 3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B;
Part Number: 151730414. 4. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 16mm B;
Part Number: 151730416. 5. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 18mm B;
Part Number: 151730418. 6. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 20mm B;
Part Number: 151730420. 7. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 22mm B;
Part Number: 151730422. 8. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 24mm B;
Part Number: 151730424. 9. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 26mm B;
Part Number: 151730426. 10. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 8mm B;
Part Number: 151730408. 11. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 10mm C;
Part Number: 151730510. 12. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 12mm C;
Part Number: 151730512. 13. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 14mm C;
Part Number: 151730514. 14. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 16mm C;
Part Number: 151730516. 15. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 18mm C;
Part Number: 151730518. 16. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 20mm C;
Part Number: 151730520. 17. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 22mm C;
Part Number: 151730522. 18. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 24mm C;
Part Number: 151730524. 19. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 26mm C;
Part Number: 151730526. 20. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 8mm C;
Part Number: 151730508. 21. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 10mm E;
Part Number: 151730710. 22. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 12mm E;
Part Number: 151730712. 23. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 14mm E;
Part Number: 151730714. 24. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 16mm E;
Part Number: 151730716. 25. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 18mm E;
Part Number: 151730718. 26. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 20mm E;
Part Number: 151730720. 27. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 22mm E;
Part Number: 151730722. 28. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 24mm E;
Part Number: 151730724. 29. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 26mm E;
Part Number: 151730726. 30. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 8mm E;
Part Number: 151730708. 31. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 10mm W;
Part Number: 151730810. 32. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 12mm W;
Part Number: 151730812. 33. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 14mm W;
Part Number: 151730814. 34. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 16mm W;
Part Number: 151730816. 35. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 18mm W;
Part Number: 151730818. 36. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 20mm W;
Part Number: 151730820. 37. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 22mm W;
Part Number: 151730822. 38. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 8mm F;
Part Number: 151730808. 39. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 24mm W;
Part Number: 151730824. 40. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 26mm W;
Part Number: 151730826.- UDI-DI
- 151730410
- 10603295529811
- 151730412
- 10603295529828
- 151730414
- 10603295529835
- 151730416
- 10603295529842
- 151730418
- 10603295529859
- 151730420
- 10603295529866
- 151730422
- 10603295529873
- 151730424
- 10603295529880
- 151730426
- 10603295529897
- 151730408
- 10603295529903
- 151730510
- 10603295529910
- 151730512
- 10603295529927
- 151730514
- 10603295529934
- 151730516
- 10603295529941
- 151730518
- 10603295529958
- 151730520
- 10603295529965
- 151730522
- 10603295529972
- 151730524
- 10603295529989
- 151730526
- 10603295529996
- 151730508
- 10603295530008
- 151730710
- 10603295530015
- 151730712
- 10603295530022
- 151730714
- 10603295530039
- 151730716
- 10603295530046
- 151730718
- 10603295530053
- 151730720
- 10603295530060
- 151730722
- 10603295530077
- 151730724
- 10603295530084
- 151730726
- 10603295530091
- 151730708
- 10603295530107
- 151730810
- 10603295544289
- 151730812
- 10603295544296
- 151730814
- 10603295544203
- 151730816
- 10603295544210
- 151730818
- 10603295544227
- 151730820
- 10603295544234
- 151730822
- 10603295544241
- 151730808
- 10603295544272
- 151730824
- 10603295544258
- 151730826
- 10603295544265
- Lot code
- 1007709
- 1007710
- 1005246
- 1005247
- AF1007712
- 1005248
- AF1008744
- 1007308
- AF1007715
- 1005251
- 1007309
- AF1009254
- 1005243
- 1008482
- AF1008370
- AF1008371
- AF1008372
- 1007067
- 1005343
- 1008374
- 1005259
- 1008376
- 1005261
- AF1008658
- 1005253
- AF1008379
- AF1008714
- 1005265
- AF1008720
- 1005267
- 1005268
- AF1005625
- 1005270
- AF1008385
- 1005262
- AF1008387
- 1005274
- 1008388
- 1007691
- 1007692
Product details
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B;
Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C;
Part Number: 151730012. 3. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN D;
Part Number: 151730014. 4. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN E;
Part Number: 151730016. 5. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN F;
Part Number: 151730018. 6. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN G;
Part Number: 151730020. 7. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN H;
Part Number: 151730022. 8. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN I;
Part Number: 151730024. 9. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN J;
Part Number: 151730026. 10. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN K;
Part Number: 151730028. 11. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN L;
Part Number: 151730030. 12. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN M;
Part Number: 151730032. 13. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN N;
Part Number: 151730034. 14. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN P;
Part Number: 151730038. 15. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN Q;
Part Number: 151730040. 16. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN R;
Part Number: 151730042. 17. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN S;
Part Number: 151730044. 18. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN T;
Part Number: 151730046. 19. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN U;
Part Number: 151730048. 20. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN V;
Part Number: 151730050. 21. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN W;
Part Number: 151730052. 22. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN X;
Part Number: 151730036.- UDI-DI
- 151730010
- 10603295534075
- 151730012
- 10603295534082
- 151730014
- 10603295534099
- 151730016
- 10603295534105
- 151730018
- 10603295534112
- 151730020
- 10603295534129
- 151730022
- 10603295534136
- 151730024
- 10603295534143
- 151730026
- 10603295534150
- 151730028
- 10603295550518
- 151730030
- 10603295550525
- 151730032
- 10603295550532
- 151730034
- 10603295550549
- 151730038
- 10603295550563
- 151730040
- 10603295550570
- 151730042
- 10603295550587
- 151730044
- 10603295550594
- 151730046
- 10603295550600
- 151730048
- 10603295550617
- 151730050
- 10603295550624
- 151730052
- 10603295550631
- 151730036
- 10603295550556
- Lot code
- AF1007816
- AF1007817
- AF1007819
- 1005405
- AF1007823
- 1005407
- AF1007983
- AF1007984
- 1005409
- 1005410
- AF1007227
- 1005412
- 1005413
- 1005414
- AF1007231
- AF1007980
- 1005417
- AF1007234
- AF1007977
- AF1007289
- AF1007290
- 1005422
- AF1007333
- AF1008548
- AF1008267
- 1005415
Recall details
- Company began the recall
- Sold in
- Company
- DEPUY (IRELAND)Co. Cork, Ireland
- Hazard
- Sterility problem
- 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
- 99078
- Recall numbers
- Z-2616-2026 to Z-2617-2026
All recalls from DEPUY (IRELAND)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
