Howmedica Osteonics Orthopaedic Implant Components
Orthopaedic implant components made from aged Uhmwpe may oxidize, causing wear and potential harm.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
2 photos
What happened
Howmedica Osteonics Corp. of Mahwah, New Jersey, began a recall on July 30, 2026, of orthopaedic implant components manufactured from UHMWPE (polyethylene), including Triathlon Hinge Inserts, Duracon XL Angled Tib Ins, Self-Pressurizing Glenoids, Axle Pin Assy Large Elbow Cobalt Chrome, Trident Poly Inserts, and other listed components.
The affected devices were manufactured with UHMWPE raw material aged in excess of five years, which may cause elevated oxidation, leading to increased wear and potential hazards such as excessive wear debris, material fragments, fractured device, or disassociated device.
The recall was added to the FDA's Enforcement Report on September 16, 2026, and distribution was worldwide, including the US Nationwide, Canada, LATAM, Europe, Asia Pacific, and South Africa.
Summary by Recall Canary from the FDA notice.
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.
Triathlon Hinge Insert Size 4 11MM 5612-P-411 Triathlon Hinge Insert Size 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327601893
- 07613327602012
- Lot
- 360958
- 5612-P-413
- 354573
Product details
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER - GLENOID #7 5361-6107 SHOULDER - GLENOID #9 5361-6109 SHOULDER - KEELED GLENOID #11 5361-6211 SHOULDER - KEELED GLENOID #5 5361-6205 SHOULDER - KEELED GLENOID #7 5361-6207 SHOULDER - KEELED GLENOID #9 5361-6209 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327138191
- 07613327138214
- 07613327138207
- 07613327138153
- 07613327138283
- 07613327138177
- 07613327138269
- 07613327138238
- Lot
- RX06413A
- C-M062-6-800
- RX06268A
- C-M062-7-500
- RX06275A
- C-M063-2-600
- RX06326A
- C-M063-5-000
- RX06350A
- RX06350AA
- 5361-6111
- AFZT00U
- AFZT00Z
- P2N04B
- P3K57
- P3K57B
- P3K57F
- PYE43B
- PZA70F
- PZA70U
- 5361-6105
- AF2S09U
- AF2S09Z
- P1H41
- P4T02
- P4T02X1
- P4T02X2
- P4T02X3
- P4T02X4
- P4T02X5
- P4T02X6
- 5361-6107
- AF3E00
- AF3E00B
- AF3E00F
- AF3E00G
- AF3E00Q
- AF3E00S
- P4A238
- P4A238X1
- P4A238X2
- P4A238X3
- P4A238X4
- P4A238X5
- P4A238X6
- P4A238X7
- P4A238X8
- P4L09
- P4L09X1
- P4L09X10
- P4L09X2
- P4L09X3
- P4L09X4
- P4L09X5
- P4L09X6
- P4L09X7
- P4L09X8
- P4L09X9
- P4N06
- P4N06X1
- P4N06X2
- P4N06X3
- P4N06X4
- P4N06X5
- P4N06X6
- P4N06X7
- P4T03
- P4T03X1
- P4T03X2
- P4T03X3
- P4T03X4
- P4T03X5
- P4T03X6
- P4T03X7
- P4T03X8
- P4V01
- P4V01X1
- P4V01X2
- P4V01X3
- P4V01X4
- P4V01X5
- P4V01X6
- P4V01X7
- P4V01X8
- 5361-6109
- AF3E02I
- AF3E02S
- AF3E02Z
- P1H39Q
- 5361-6211
- AFZS09F
- AFZS09G
- AFZS09S
- P2N08
- PYC30X1
- PYW24X1
- PZKDHX1
- 5361-6205
- 1NMMPE
- 1NNMPE
- P3K58
- P3K58B
- P3K58F
- 5361-6207
- AF2S10B
- AF2S10F
- AF2S10G
- P4A241
- P4A241X1
- P4A241X2
- P4A241X3
- P4V03
- P4V03X1
- P4V03X2
- P4V03X3
- P4V03X4
- P4V03X5
- PZKDFX1
- 5361-6209
- AF2K03Z
- AFZS10S
- AFZS10U
Axle PIN Assy Large Elbow Cobalt Chrome Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Lot
- P22E159
Trident 0¿ Poly Insert 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327313581
- Lot
- MHANP2
- MHD1N0
Product details
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRAINED INSERT 22D 690-00-22D TRIDENT 0 DEG CONSTRAINED INSERT 22E 690-00-22E TRIDENT 0 DEG CONSTRAINED INSERT 28F 690-00-28F TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G TRIDENT 0 DEG CONSTRAINED INSERT 32I 690-00-32I TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D TRIDENT CONSTR ACET INSERT 690-10-28K TRIDENT CONSTRAINED INSERT 690-10-22E 690-10-22F 690-10-28G 690-10-28H 690-10-28I Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327038538
- 07613327025446
- 07613327025453
- 07613327025460
- 07613327025477
- 07613327025484
- 07613327031430
- 07613327031447
- 07613327031454
- 07613327031591
- 07613327138870
- 07613327138979
- 07613327025538
- 07613327025545
- 07613327025552
- 07613327025583
- 07613327025590
- 07613327313581
- 07613327024449
- 07613327024289
- Lot
- 191723
- 191867
- 69-2244
- 990V1W
- D56JV4
- D74X5E
- DX56K2
- E67D6N
- EP10WL
- KP14HN
- NN8NM2
- P36TXM
- P95L8X
- RE4EK0
- X82K0D
- 69-2246
- 8X6EL1
- 69-2248
- 9J3DPH
- A41E7D
- AD39A3
- RP673W
- 69-2850
- MLL1M3
- MLLXT1
- MLLY6H
- 69-2852
- MLL0NM
- 2099-2250
- 1K5VVW
- 2367AK
- 3X0NJD
- 4W4MPL
- LV80NE
- 2099-2252
- NV561W
- PM326V
- 2099-2256
- 3H5RRK
- AA7JK0
- 2099-2861
- MLLVL6
- 6636-0-419
- 13SFLA
- 6299-N-332
- 19ECK
- 6302-H-632
- 15NKT
- 690-00-22D
- 123J5R
- 194RN0
- 274HMK
- 3M77NN
- 5J8P89
- 5L82T0
- 986HVM
- A23P1X
- E923WW
- MLMEW8
- MLNPX0
- VX6813
- 690-00-22E
- 4100R9
- 5V78KA
- 711K4K
- EY7HL9
- KP576W
- L620XW
- MD8JH9
- T61W43
- XA0L27
- 690-00-28F
- 284X4X
- 2K2DW1
- E47WVY
- MLL8JJ
- MLLP6K
- MLLYT7
- YE6959
- 690-00-28G
- 6D8274
- 9N8EWW
- 690-00-32I
- 3A2P68
- 4A40TV
- 620-00-28D
- MET76R
- 690-10-28K
- MHNRM4
- MKRH1M
- MLAAV7
- 690-10-22E
- 29385D
- 906WEN
- DJ7TP1
- EK4TK5
- LA22KA
- WL248Y
- XV01J8
- 690-10-22F
- A6592H
- L7140Y
- P103P0
- W745P8
- 690-10-28G
- MLL4Y7
- 690-10-28H
- MLKNT7
- MLL1YN
- 690-10-28I
- MLL8L9
Product details
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS 72-4-9114 SCORPIO TS TIBIAL INSERT 72-4-0324 SCORPIOFLEX TOTAL KNEE CR 72-16-0512 72-16-0518 72-16-0912 72-16-1112 SERIES II TIBIAL BEAR INSERT NO 11 15MM 3052-1115 UHR BIPOLAR 26X52mm UH1-52-26 UHR BIPOLAR 26X58mm UH1-58-26 UHR BIPOLAR 28X48mm UH1-48-28 UHR BIPOLAR 28X52mm UH1-52-28 UHR BIPOLAR 28X55mm UH1-55-28 UHR BIPOLAR 32X49MM UH1-49-32 UHR BIPOLAR 32X51MM UH1-51-32 UHR BIPOLAR 32X52MM UH1-52-32 UHR BIPOLAR 32X54MM UH1-54-32 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327025491
- 04546540400611
- 23325151
- 04546540400635
- 23640051
- 04546540400758
- 26862851
- 04546540364319
- 28208551
- 07613327366006
- 30582401
- 30582601
- 07613327033847
- 07613327014082
- 07613327050288
- 07613327050295
- 07613327050332
- 07613327033779
- 07613327034875
- 07613327034356
- Lot
- MLKY8A
- MLL8E1
- 82-2-0512
- 82-2-0518
- 82-2-0912
- 82-3-0318
- 78-5-0910
- 73-2710
- 14HDSA
- 73-2610
- 193307A
- 193307E
- 73-0110
- 73-0710
- 8P83
- DL4V
- 73-0910
- 14NACD
- 3044-0026
- 14SCVA
- 14SCVD
- 14SCVF
- 72-4-9114
- 8H39KP
- 72-4-0324
- 23505751
- 72-16-0512
- 17376651
- 19093651
- 23125951
- 27835951
- 72-16-0518
- 25621551
- 72-16-0912
- 17879451
- 72-16-1112
- 22764851
- 3052-1115
- MJ7YY6
- UH1-52-26
- 5J8PM2
- UH1-58-26
- 1R8TNH
- 414A2L
- 4W1HD7
- AV0J7J
- E226XA
- E50DAW
- M31665
- WK1WP2
- X90ML6
- UH1-48-28
- N046DW
- N06WWP
- N20WDM
- N75AY1
- P419XW
- RP3D0X
- TD218R
- V15WA1
- VH06PA
- VN3P18
- VR853H
- WM8KJT
- XE2ND8
- YH0N93
- UH1-52-28
- V02MME
- UH1-55-28
- R30MME
- UH1-49-32
- 324H9H
- UH1-51-32
- 9J6N9E
- UH1-52-32
- 5D4NMJ
- 9T612E
- UH1-54-32
Scorpio + Mobile Bearing PCS 78-5-0910 System One Bipolar 40MM 6074-4022 System One Bipolar 43MM 6074-4322 System One Bipolar 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327366006
- 30582401
- 07613327031775
- 07613327031805
- 07613327031812
- Lot
- 6074-4022
- 2M5NTY
- LH25R5
- M36N83
- 6074-4322
- W40E3T
- 6074-4422
- R84K20
Product details
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327590074
- Lot
- MH621A
- C-M113-5-600
- 194593
- C-M063-5-800
- RX06358A
Scorpio Recessed Metal Backed Patella 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Lot
- 12WAHA
- 12WAHB
- 3045-0028
- 13VAW
- 13VAWA
- 3045-0030
- 3045-0032
Product details
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT LG 12MM MED 14MM LAT C-M066-3-000 EXETER WINGLESS CENTRALISER FOR C-M082-7-302 C-M082-7-303 EXETER WINGLESS CENTRALIZER XSM C-M107-5-301 GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm C-MM100616-02 GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm C-MM100616-03 GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm C-MM100616-01 GMRS SML POLY TIBIA 11MM CASE 100520 C-MM100520-03 GMRS SML POLY TIBIA 16MM CASE 100520 C-MM100520-04 GMRS SML POLY TIBIA 8MM CASE 100520 C-MM100520-02 GMRS SML TIBIA 11MM WITH CASE 100411 C-MM100411-03 GMRS SML TIBIA 14MM WITH CASE 100411 C-MM100411-04 GMRS SML TIBIA 8MM WITH CASE 100411 C-MM100411-02 GMRS TIB INSRT SML 10MM WITH CASE 100507 C-MM100507-04 GMRS TIB INSRT SML 16MM WITH CASE 100507 C-MM100507-06 KALI TIBIAL INSERT LARGE RIGHT 8mm C-M071-6-601 KRH REV TIB INS 16mm THK .655 DIA STEM C-M113-5-603 MRH KNEE TIBIAL INSERT FOR THIN POST C-M067-3-103 MRS RADIAL BUSHING FORITH C-M107-7-800 C-M107-7-801 SELF-PRESSURIZING GLENOID SIZE 9 C-M064-4-300 TRIATHLON NO. 9 TIBIAL INSERT 11MM C-M067-5-003 TRIATHLON NO. 9 TIBIAL INSERT 9MM C-M067-5-002 TRIDENT ALL POLY CUP 44 X 66MM C-M066-0-901 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE A X 22mm ID UH1 C-M104-2-002 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE B X 22mm ID UH1 C-M104-2-003 UHR BIPOLAR 22X38MM UH1-38-22 UHR BIPOLAR 22X40MM UH1-40-22 UHR BIPOLAR 22X41MM UH1-41-22 UHR BIPOLAR 22X42MM UH1-42-22 UHR BIPOLAR 22X43MM UH1-43-22 UHR BIPOLAR 22X45MM UH1-45-22 UHR BIPOLAR 26X41mm UH1-41-26 UHR BIPOLAR 26X42mm UH1-42-26 UHR BIPOLAR 26X43mm UH1-43-26 UHR BIPOLAR 26X44mm UH1-44-26 UHR BIPOLAR 26X45mm UH1-45-26 UHR BIPOLAR 26X46mm UH1-46-26 UHR BIPOLAR 26X47mm UH1-47-26 UHR BIPOLAR 26X48mm UH1-48-26 UHR BIPOLAR 28X42mm UH1-42-28 UHR BIPOLAR 28X44mm UH1-44-28 UHR BIPOLAR 28X45mm UH1-45-28 UHR BIPOLAR 28X46mm UH1-46-28 UHR BIPOLAR 28X47mm UH1-47-28 UHR BIPOLAR 28X48mm UH1-48-28 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327504811
- 07613327016789
- 07613327016796
- 07613327016819
- 07613327016833
- 07613327016840
- Lot
- G3264034
- C-M071-6-700
- G3043883
- C-M071-8-400
- G3043878
- C-M110-1-201
- 573P37
- C-MM100253-02
- N8873H
- C-M066-3-000
- RX06630A
- C-M082-7-303
- L6237
- C-M107-5-301
- 193607
- C-MM100616-02
- 195261
- C-MM100616-03
- 195262
- C-MM100616-01
- 195260
- C-MM100520-03
- 195081
- C-MM100520-04
- 195082
- C-MM100520-02
- 195080
- C-MM100411-03
- 194962
- C-MM100411-04
- 194963
- C-MM100411-02
- 194961
- C-MM100507-04
- LNH795
- C-MM100507-06
- LNH797
- C-M071-6-601
- G3055684
- C-M113-5-603
- 194594
- C-M067-3-103
- MHP0AX
- C-M107-7-801
- 193479
- C-M064-4-300
- RX06443A
- C-M067-5-003
- RX06750D
- C-M067-5-002
- RX06750C
- C-M066-0-901
- RX06609B
- C-M104-2-002
- 192371
- C-M104-2-003
- 192370
- UH1-38-22
- 2A01TA
- 430715
- 49510K
- 7E5X23
- 852J98
- D23664
- NE659N
- UH1-40-22
- 128LXW
- 16182H
- 1J5955
- 1T8203
- 2137N4
- 2541YM
- 2Y52Y2
- 4E19VD
- 4K7XYL
- 577M4L
- 5D3AVR
- 746AV4
- 7V8J0V
- 828TAR
- 875M72
- 8V63LX
- 9A3W5N
- A91P07
- DL4D38
- LW709R
- RA6A1H
- VT4K59
- X95RTV
- UH1-41-22
- 343653
- 4P1TR7
- 521MLK
- 7Y8HEA
- 975A6Y
- AR0KX5
- E788E6
- KL1YTE
- KN0086
- P043ME
- PL4L5M
- UH1-42-22
- 1R2VD1
- 2E84HD
- 2X333W
- 4L5YMY
- 6J2W2P
- 7238R2
- 7883W1
- 7H2L8M
- 8K315D
- AK2P91
- ET3HWR
- L16J85
- L93PY2
- ME1485
- MY1N20
- P987D0
- R92PDW
- TM0KR0
- X884ET
- XD3961
- YK39TT
- UH1-43-22
- 11138V
- 23005R
- 481KR9
- 516JLV
- 761T5M
- 9W3NWV
- DA0W51
- EK6069
- KP0AAD
- MD1Y5V
- NT68KL
- RT8N8H
- RY828P
- UH1-45-22
- 8Y0KWH
- HR869M
- R7168K
- WR4MT4
- UH1-41-26
- 157V1T
- 1D33YX
- 1K1E6M
- 1R5LWT
- 218RED
- 254MT3
- 287D4A
- 2K7HXW
- 2X5MTA
- 3J1A39
- 3K3P0T
- 473K4V
- 5A1T5N
- 5D6KJ5
- 5V7H82
- 6J8XKT
- 6W1MKA
- 8R29TH
- 9T7N8Y
- AL5K8M
- AW02V8
- DT8JEW
- H04PHL
- JR6R9L
- LN70PY
- MA6M6E
- PE7T6P
- PY8PLH
- RY49EW
- T1497X
- V70PNP
- VJ6WXM
- X82M1D
- UH1-42-26
- 186JE6
- 5Y1RL7
- 618AMX
- 7J0XET
- MLKT5A
- MLL022
- MLL05K
- R50NW2
- UH1-43-26
- 192J0R
- 1D45L5
- 1H5V53
- 2P2A99
- 2V6D0R
- 3248V2
- 334851
- 386P0V
- 3N33VT
- 402RP3
- 4644KD
- 4J5Y6H
- 4L3JPP
- 5H1A45
- 5Y2422
- 626J60
- 6E33NR
- 6J30X2
- 6M2KK8
- 6V092N
- 761EJP
- 7820L1
- 791NPH
- 7D0H4K
- 7K28Y8
- 7K63EE
- 7N7WX1
- 817AJJ
- 8J6TAL
- 8L6R73
- 8T3XDK
- 983JDR
- 998H5N
- 9E631T
- A93KWD
- AY40L3
- DJ105H
- E521L6
- EX5DA9
- HW7XYK
- J94M7R
- JT565R
- JX0L8R
- K939KP
- KA30HV
- KE5770
- KP1Y0E
- KV3L3H
- MD76WR
- MJ1DY9
- MK2MN3
- MLL54K
- MLL65N
- MLLV64
- MR6D42
- MW2J8W
- N314DK
- NP48X0
- P147V0
- P502R8
- P92DV1
- RL1TL1
- RN8NM1
- T66JK4
- TA20N9
- TT3EJR
- TV197Y
- TY7YV5
- V68NXH
- V91EK1
- VW74NJ
- VX5T02
- VY0525
- WA0VRE
- WT7P1A
- X48P1Y
- Y63LYJ
- Y648WL
- YE3W2X
- YJ6PHM
- YL3HVY
- YL6L7K
- YX8NTJ
- UH1-44-26
- 336652
- 581XTY
- 5H1YRH
- 640Y4R
- 7Y7H14
- 9J7T4L
- A881HX
- JN7TXM
- KT4P91
- LJ44JX
- M52APN
- MLL2PT
- MLL5X1
- MLLD4R
- MLLPK1
- MLLV2Y
- NR773K
- NV0NVX
- PD7P36
- R74D1D
- T31P16
- VK7JL5
- W91ENE
- XD45XY
- XN8EWL
- Y385N4
- YN1AJN
- UH1-45-26
- 056MNE
- 059MNE
- 188AWK
- 243WTY
- 352XY0
- 442K1P
- 8L58NK
- AJ0H2R
- AN15H5
- HX6PAR
- HY2V81
- L50T23
- MLL0AE
- MLL5J4
- MLL9TV
- N88PKJ
- P31A9Y
- RJ8JPR
- UH1-46-26
- 1839Y2
- 1M2AX3
- 1P2E82
- 1V5AN9
- 226AWD
- 232X83
- 2465J7
- 2K0P93
- 2R3XD6
- 3614YL
- 394D8M
- 3P7091
- 4V2PVP
- 5389M0
- 5N2N75
- 9X7YK5
- A35V7K
- DW3J8W
- DY85VA
- E242NY
- H07J22
- JV88X1
- L04PPV
- LY44K5
- MLL50M
- MLL789
- MLLA53
- NE45DD
- V94NTT
- YY5N98
- UH1-47-26
- 1Y2K34
- 21197T
- 3E0A48
- 4E7MKW
- 7K1VLW
- A58HN9
- J38RE2
- J60A4E
- LT43X0
- M15HKN
- MK442Y
- MLL2LR
- MLL52N
- XD724J
- UH1-48-26
- 1J8K9L
- 2Y6JK3
- 350D6V
- 3845V3
- 3D6216
- 44827N
- 580Y68
- 726W7P
- 7L7TPP
- 8E7A1J
- 9V8P94
- 9Y6HML
- H88E74
- K54MN4
- L783M7
- MLL3E9
- MLL52W
- MP56YN
- N00HDA
- N26TW7
- TR4TT5
- W016KY
- XJ48DN
- YA4YPN
- UH1-42-28
- 1R5MDV
- 275NEA
- 2V6KMY
- 4215LV
- MLLJ5X
- MLLJK9
- MLLV75
- UH1-44-28
- 106X12
- 121A72
- 123MX4
- 138KNV
- 1401YE
- 1429X2
- 154N34
- 1740KE
- 1830AR
- 186WEL
- 1D8LYA
- 1E4HK2
- 1E6W32
- 1E7RRN
- 1H1P69
- 1K10H5
- 1K58A6
- 1K63LK
- 1M1W89
- 1M6JWR
- 1N6VPP
- 1R8333
- 1V4LXR
- 1X8R7X
- 1Y2V83
- 1Y7DPY
- 201MY5
- 2116XX
- 2286V1
- 25090N
- 251WMR
- 2550NN
- 261Y8Y
- 287N2R
- 2D4N58
- 2X5T7Y
- 335351
- 335EXD
- 391JXR
- 3K6YR2
- 444636
- 4E45R8
- 4K15YY
- 4L17DL
- 4L29A4
- 4M7J5A
- 4N2091
- 4P3L83
- 4T85VA
- 4W227H
- 518WTR
- 521K2M
- 5246AR
- 5325D6
- 534JYN
- 555249
- 558TVA
- 581YM9
- 5D1Y5V
- 5H0EXH
- 5K0AMY
- 5P0H6D
- 5R3H24
- 5V2RJ0
- 600TDM
- 623LA2
- 6370A6
- 681Y0M
- 6885NJ
- 693MRX
- 698Y2M
- 6L4LT7
- 6N4J52
- 6T3JAY
- 6V19AE
- 6V6DW2
- 6W0A59
- 7307MN
- 758K2A
- 768V6X
- 7D5MN2
- 7L230N
- 7M6YVP
- 7X2PH3
- 7X7XM0
- 8125RN
- 867YNX
- 886V7A
- 8E6V9P
- 8M114H
- 8M4W64
- 8R438X
- 8X4PRJ
- 971KAN
- 987WJ0
- 9H673H
- 9K656K
- 9V0L0L
- A56J67
- A85T4Y
- A86V5E
- AA7VL4
- AM3PPW
- AW6JML
- DD37HD
- DH5N6T
- DL5E4X
- DR69YE
- E47VAT
- EA6WY1
- EK5N6A
- EK8KDD
- EN17M3
- ER2VAV
- HW14NW
- J477D9
- J63M24
- J644K6
- JE7K73
- JT2PYD
- K47JDR
- KD174L
- L548RP
- LE83EE
- LH10XA
- LM74JP
- LR3KT5
- LV0PP9
- M45LKM
- MLL0X7
- MLL3T3
- MLL3X8
- MLL3YN
- MLL5V9
- MLL6E1
- MLL70V
- MLLA90
- MLLR0R
- MLLY2V
- MT2YK4
- MT56MX
- N082LN
- N35W9W
- N4476X
- N60KXY
- N780A7
- N80J7M
- NR5X7N
- NW7H6M
- PN3K4T
- PV87N1
- R20NVJ
- RM8HJJ
- RY4JDM
- T6297W
- T73HN0
- TP366X
- V281XV
- V64XWE
- V95MVD
- VA7769
- VL3RJJ
- VP8E88
- W33XH8
- W969RX
- WD03AK
- WJ4YYD
- WK2AHL
- WW6MVP
- X16M08
- XM319D
- XN437D
- Y703W8
- YJ012E
- YV08TH
- YY4TKX
- UH1-45-28
- 1A3013
- 360RPN
- 486EJ1
- 4N85AM
- D6348Y
- EY829J
- MLL1V3
- MLL210
- MLL24J
- MLL44A
- MLL5RM
- MLL94Y
- MLLW3M
- MLLY7V
- X43WJN
- UH1-46-28
- 1804DD
- 29772K
- 2E5PX4
- 3402DJ
- 3P0NDP
- 4H0W7N
- 4J5R3M
- 4K0NDA
- 5818XA
- 5R5H8L
- 6N77PT
- 6T493L
- 7K0L36
- 7L1KRT
- 8015WY
- 802XY1
- 8P7D00
- 905HH2
- AD0E56
- D3227P
- E83XET
- EV4W50
- HT21XV
- JP0TKR
- L00E8N
- M25670
- MLL0Y0
- MLL1W9
- MLL46R
- MLL499
- MLL602
- MLL8Y7
- MLLDY9
- MLLK40
- MLLNE3
- MLLRL2
- MLLV8T
- MLLXV3
- MR613J
- NT30DY
- P72N17
- VE411K
- WH517T
- XH01PP
- Y66HVE
- YE5XLP
- UH1-47-28
- 2821VP
- 2N68HT
- 3682T6
- 3M0Y7N
- 4E58YD
- 661DW6
- 8K6225
- 8M60J8
- 9D22DE
- 9Y0X3H
- A68HK5
- AL4LYE
- J60DLA
- KM65D9
- LJ3RRT
- MLL8V0
- MLL984
- MLLH9P
- MLLND6
- PV1K03
- PW100N
- TD5KRD
- WX0R02
- UH1-48-28
- 1831VA
- 1M4NYV
- 1T0L93
- 1W0E1J
- 254N4A
- 294M71
- 2A2RJ0
- 2T45AP
- 3K8VM4
- 3T6PD5
- 3Y8DJX
- 437ANA
- 448V4T
- 4623VM
- 484LE9
- 4X0M53
- 5D50WT
- 5L074T
- 5T0PX8
- 6E2MX7
- 6K5Y7V
- 6L43JP
- 7A1HVY
- 8J8DDN
- 975VXR
- 9786P2
- 9D6M48
- 9M6KHT
- 9T2991
- 9X5MJ3
- A228M1
- A54PLW
- A77V1M
- AV5ANE
- AX18R8
- DK0M6J
- DY3LR8
- E600KE
- EY5P9V
- H558EP
- H63W11
- HP74LE
- J72DLP
- J76YJ6
- JK7JY4
- JL1T01
- K47WL6
- K728DH
- KT3K27
- L35VMM
- M15D88
- ML731E
- MLL18D
- MLL562
- MLL6MH
- MLL74R
- MLLM4T
- MLLPV9
- MLLV38
- MLLX14
Scorpio C-Dome Patella 73-2710 73-2910 Scorpio U-Dome Patella 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327033847
- 07613327033854
- 07613327033861
- 07613327033885
- 07613327033892
- 07613327033908
- 07613327033915
- Lot
- 73-2910
- 14AGFD
- 73-3110
- 1L45
- 4JM5
- 7EL5
- AME3
- MK74
- NTV7
- RE7J
- 73-3508
- HMM5
- 73-3708
- 3467
- 3D8D
- PMRHX1
- T6YJ
- T9ME
- YAM7
- 73-3710
- 3W25
- 73-3910
- 14NEYA
- 1XED
- 9Y3T
- D1M9
- D2YP
- EX8T
- KRT3
- KRT3X1
- T325
- V8X8
- X6YE
Omnifit Series I Acet. Insert 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- UDI-DI
- 07613327037883
- Lot
- 13MFT
Details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Event ID
- 99558
- Recall numbers
- Z-3195-2026 to Z-3206-2026
- Company
- Howmedica Osteonics Corp.Mahwah, New Jersey
- Hazard
- Device defect
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
