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FDAFDA · Food and drugs·Recall number Z-1982-2012

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.

Published July 18, 2012 · Recall initiated: December 29, 2011

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Stryker Howmedica Osteonics Corp.
Distributor
Nationwide Distribution
Lot
Listed as Catalogue Number followed by Lot Number: 6265-3-099 8024501 6265-3-099 8024502 6265-3-099 11160601 6265-3-099 11650201 6265-3-099 11650202 6265-3-099 12915801 6265-3-099 12915802 6265-3-099 12915803 6265-3-099 12915804 6265-3-099 12915805 6265-3-099 14027701 6265-3-099 14027702 6265-3-099 14503501 6265-3-099 14525001 6265-3-099 14525002 6265-3-099 14525003 6265-3-099 19943601 6265-3-099 19943602 6265-3-099 19943603 6265-3-099 19943604 6265-3-099 21500101 6265-3-099 21500102 6265-3-099 22108201 6265-3-099 22108202 6265-3-099 22260101 6265-3-099 23164201 6265-3-099 23731701 6265-3-099 23731801 6265-3-099 23731802 6265-3-099 23731803 6265-3-099 23843302 6265-3-099 23843303 6265-3-099 23843304 6265-3-099 23843305 6265-3-099 23843306 6265-3-099 23844101 6265-3-099 24321501 6265-3-099 24321502 6265-3-099 24321503 6265-3-099 24589701 6265-3-099 24589702 6265-3-099 24589703 6265-3-099 24589704 6265-3-099 25025901 6265-3-099 25025902 6265-3-099 25025903 6265-3-099 25025904 6265-3-099 27951601 6265-3-099 27951602 6265-3-099 27951603 6265-3-099 27951604 6265-3-099 27951605 6265-3-099 28008201 6265-3-100 18010702 6265-3-100 18363101 6265-3-100 18363102 6265-3-100 18363103 6265-3-100 18363104 6265-3-100 18981801 6265-3-100 19253701 6265-3-100 19253702 6265-3-100 19601801 6265-3-100 19602301 6265-3-100 19602302 6265-3-100 19898201 6265-3-100 19898202 6265-3-100 19898203 6265-3-100 19898204 6265-3-100 20507301 6265-3-100 20507302 6265-3-100 20542501 6265-3-100 20542502 6265-3-100 20953101 6265-3-100 22260201 6265-3-100 22260202 6265-3-100 22349901 6265-3-100 22349902 6265-3-100 22441501 6265-3-100 22441502 6265-3-100 22499401 6265-3-100 32573902 6265-3-100 34145101 6265-3-100 34145102 6265-3-100 34145103 6265-3-100 34145104 6265-3-100 34145105 6265-3-100 34145106 6265-3-100 34748701 6265-3-100 34748702 6265-3-100 34748901 6265-3-100 34748903 6265-3-100 34748904 6265-3-100 35484501 6265-3-100 35484502 6265-3-100 35484503 6265-3-100 35484504 6265-3-100 36275202 6265-3-100 10212101R 6265-3-100 10316601R 6265-3-100 10316602R 6265-3-100 12037201R 6265-3-100 18718001R 6265-3-100 6645204R 6265-3-100 7898301R 6265-3-100 9718501R 6265-3-100 D3KTER 6265-3-100 D3KTJR 6265-3-101 7766001 6265-3-101 7766002 6265-3-101 7766003 6265-3-101 7836503 6265-3-101 7836504 6265-3-101 7851301 6265-3-101 7851302 6265-3-101 7851303 6265-3-101 8024701 6265-3-101 8024702 6265-3-101 8154301 6265-3-101 8154302 6265-3-101 8154303 6265-3-101 8220101 6265-3-101 8220102 6265-3-101 8367803 6265-3-101 8367804 6265-3-101 8908201 6265-3-101 8931701 6265-3-101 8931702 6265-3-101 8939001 6265-3-101 8965501 6265-3-101 8965502 6265-3-101 9027301 6265-3-101 9027302 6265-3-101 9051301 6265-3-101 9051302 6265-3-101 11335201 6265-3-101 11335202 6265-3-101 11335203 6265-3-101 11335204 6265-3-101 11495201 6265-3-101 11528501 6265-3-101 11528502 6265-3-101 11528503 6265-3-101 11790801 6265-3-101 11790802 6265-3-101 11790803 6265-3-101 11978401 6265-3-101 11978402 6265-3-101 11978403 6265-3-101 11978404 6265-3-101 11978405 6265-3-101 11995702 6265-3-101 11995703 6265-3-101 11995704 6265-3-101 12064201 6265-3-101 12064203 6265-3-101 12144701 6265-3-101 12144702 6265-3-101 12144703 6265-3-101 12144704 6265-3-101 12144705 6265-3-101 12725101 6265-3-101 14106902 6265-3-101 14150301 6265-3-101 14150302 6265-3-101 14150303 6265-3-101 14150304 6265-3-101 14422501 6265-3-101 14422502 6265-3-101 14422503 6265-3-101 14422504 6265-3-101 14422505 6265-3-101 14422506 6265-3-101 14468602 6265-3-101 14468604 6265-3-101 14468605 6265-3-101 14468606 6265-3-101 14485701 6265-3-101 14485702 6265-3-101 14485703 6265-3-101 14485704 6265-3-101 14485705 6265-3-101 14485706 6265-3-101 14504001 6265-3-101 14504002 6265-3-101 14504003 6265-3-101 14504004 6265-3-101 14504005 6265-3-101 14524901 6265-3-101 17674804 6265-3-
Risk classification
Class II
Area (FDA)
device
Country
United States

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