Product Wiki · Recalls · U.S. FDA — Device Enforcement

Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers… — recall Z-1982-2012

U.S. FDA — Device Enforcement · United States · 2011-12-29 · Class II

As described by U.S. FDA — Device Enforcement: 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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1982-2012
Date of alert
2011-12-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution
Reported risk: Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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