Reported Jul 18, 2012 · Terminated
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Drive · Mahwah, NJ · 07430
Is this the product you have?
- 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.
- Lot codes and dates
- Listed as
- Catalogue Number followed by Lot Number
3,136 of 3,136 codes
6265-3-09980245016265-3-09980245026265-3-099111606016265-3-099116502016265-3-099116502026265-3-099129158016265-3-099129158026265-3-099129158036265-3-099129158046265-3-099129158056265-3-099140277016265-3-099140277026265-3-099145035016265-3-099145250016265-3-099145250026265-3-099145250036265-3-099199436016265-3-099199436026265-3-099199436036265-3-099199436046265-3-099215001016265-3-099215001026265-3-099221082016265-3-099221082026265-3-099222601016265-3-099231642016265-3-099237317016265-3-099237318016265-3-099237318026265-3-09923731803
- Amount recalled
- 16,913 units
Where it was sold
- Nationwide
Why it was recalled
Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
This product could cause temporary or reversible health problems — stop using it.
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