—#68198

Product

Stryker Trial Head xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6264-8-528; Howmedica Osteonics Corp. Styrker Ireland; Carrigwohill Inustrial Estate; Carrigtwohill county Cork, Ireland. Made in Ireland.

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: 28mm +16mm TRIAL HEAD-- Product Number: 6264-8-528 All Lot codes

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2007-11-02
Posted by FDA: 2008-02-07
Terminated: 2010-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68198. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.