Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number 6264-8-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigwohill Inustrial Estate; Carrigtwohill county Cork, Ireland. Made in Ireland.
FDA Recall Z-0968-2008 · Posted 2008-02-07
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDI
Date Initiated2007-11-02
Date Terminated2010-08-30
Product Quantity5,599 total units
Reason for Recall
Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.
Firm Action
Stryker Orthopaedics sent an Urgent Product Recall notification letters on November 9, 2007, by Federal Express with return receipt. The letter informed users of potential increased risk of stem neck fracture, when a V40 + 16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese. The firm has asked that inventory be examined, removed and held in quarantine. A Stryker representative will contact the medical facilities to retrieve the product. If a representative has not contacted the facility to date, it is suggested that they contact Stryker at (201) 831-5972.
Root Cause
Other
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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