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Terminated

Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116

FDA Recall Z-0389-2010 · Posted 2009-11-20

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeJDI
Date Initiated2009-01-23
Date Terminated2012-02-07
Product Quantity925 units

Reason for Recall

Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision.

Firm Action

All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. Further questions are directed to the contacts at Smith and Nephew listed in the letter.

Root Cause

Other

Distribution Pattern

Nationwide; 17 international: Switzerland, Dubai, Brazil, Canada, South Africa, Australia, Belgium, Spain, Thailand Turkey, Costa Rica, Denmark, India, Italy, and France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030766OXINIUM FEMORAL HEADSSmith & Nephew, Inc. · 2003-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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