Stryker Orthopaedics — Class II medical device recall Z-1982-2012
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2012-07-18, distributed nationwide. Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip S
| Recall number | Z-1982-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2011-12-29 |
| Classified | 2012-07-10 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2015-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 16,913 units |
| Reason classes | packaging |
| Lot numbers | 10004401, 10004402, 10004403, 10004404, 10004601, 10004602, 10025502, 10025503, 10025504, 10026401, 10082901, 10082902, 10163201, 10163202, 10211601, 10211602, 10211603, 10211604, 10212001, 10212002, 10212101, 10212101R, 10220201, 10262001, 10262002, 10262003, 10262004, 10262005A, 10262301, 10262302, 10316601, 10316601R, 10316602, 10316602R, 10368401, 11060301, 11060302, 11060303, 11060304, 11078402 and 460 more |
| Model numbers | 6265-3-099 |
Product
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.
Reason for recall
Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.