Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Smith & Nephew Inc
- UPC
- Lot Numbers: 08BM09885, 08EM06396, 08FM14910, 08HM10480, 08KM07754, 08KM12526, 08HM03206, 08GM03007R, 08EM19444, 08EM19445, 08EM19446, 08EM20186, 08FM00231, 08RM00242, 08FM03526, 08FM04628, 08FM05689, 08FM06247, 08FM14906, 08FM17347, 08FM22085, 08FM22087, 08GM03007, 08GM03489, 08GM06660, 08GM11382, 08GM11425, 08GM12094, 08GM13061, 08GM17805, 08GM18609, 08HM02631, 08HM03926, 08HM10037, 08HM13107, 08HM13118, 08HM16147, 08HM16150, 08HM17621, 08HM18516, 08JM00370, 08JM04970, 08JM04971, 08JM05505, 08JM05506, 08JM08122, 08JM09041, 08JM11262, 08JM14571, 08JM15417, 08JM19246, 08JM19247, 08JM19248, 08JM20328, 08JM21716, 08JM21717, 08JM21718, 08KM03713, 08KM07732, 08KM14807, 08KM20680, 08KM23716, 08LM01328, 08LM02300, 08LM11759, 08LM12842, and 08LM13924
Units Affected
925 units