Howmedica Osteonics Corp. recalls ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82

Recalling company

Howmedica Osteonics Corp.

Product

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)

Reason

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jul 30, 2026

Reported

Sep 23, 2026

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Status

Ongoing

Quantity

12,156 US

Lot / codes

69-2854 UDI-DI 07613327025491 Lots MLKY8A MLL8E1 82-2-0512 UDI-DI 04546540400611 Lot 23325151 82-2-0518 UDI-DI 04546540400635 Lot 23640051 82-2-0912 UDI-DI 04546540400758 Lot 26862851 82-3-0318 UDI-DI 04546540364319 Lot 28208551 78-5-0910 UDI-DI 07613327366006 Lots 30582401 30582601 73-2710 UDI-DI 07613327033847 Lot 14HDSA 73-2610 UDI-DI 07613327014082 Lots 193307A 193307E 73-0110 UDI-DI 07613327050288 Lot HHPW 73-0710 UDI-DI 07613327050295 Lots 8P83 DL4V 73-0910 UDI-DI 07613327050332 Lot 14NACD 3044-0026 UDI-DI 07613327033779 Lots 14SCVA 14SCVD 14SCVF 72-4-9114 UDI-DI 07613327034875 Lot 8H39KP 72-4-0324 UDI-DI 07613327034356 Lot 23505751 72-16-0512 UDI-DI 07613154020515 Lots 17376651 19093651 23125951 27835951 72-16-0518 UDI-DI 07613154020539 Lot 25621551 72-16-0912 UDI-DI 07613154020652 Lot 17879451 72-16-1112 UDI-DI 07613154020737 Lot 22764851 3052-1115 UDI-DI 07613327034240 Lot MJ7YY6 UH1-52-26 UDI-DI 07613327017168 Lot 5J8PM2 UH1-58-26 UDI-DI 07613327017359 Lots 1R8TNH 414A2L 4W1HD7 AV0J7J E226XA E50DAW M31665 WK1WP2 X90ML6 UH1-48-28 UDI-DI 07613327017014 Lots N046DW N06WWP N20WDM N75AY1 P419XW RP3D0X TD218R V15WA1 VH06PA VN3P18 VR853H WM8KJT XE2ND8 YH0N93 UH1-52-28 UDI-DI 07613327017182 Lot V02MME UH1-55-28 UDI-DI 07613327017

Company location

Mahwah, NJ

Recall type

Voluntary: Firm initiated

Recall number

Z-3197-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3197-2026 in the FDA Enforcement Report. Also see FDA recall press releases.