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.
FDA Recall Z-1982-2012 · Posted 2012-07-10
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDI
Date Initiated2011-12-29
Date Terminated2015-03-19
Product Quantity16,913 units
Reason for Recall
Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
Firm Action
Stryker Orthopaedics sent an Urgent Product Recall letter dated January 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of any affected product. Customers were also asked to fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For any questions customers should call 201-972-2100.
For any questions regarding this recall please call 201-831-5970.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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