| Class 2 Device Recall Oxinium | |
Date Initiated by Firm | January 23, 2009 |
Date Posted | November 20, 2009 |
Recall Status1 |
Terminated 3 on February 07, 2012 |
Recall Number | Z-0389-2010 |
Recall Event ID |
52615 |
510(K)Number | K030766 |
Product Classification |
Hip joint metal/polymer semi-constrained cemented prosthesis - Product Code JDI
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Product | Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116 |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
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For Additional Information Contact | Victor Rocha 901-399-6771 |
Manufacturer 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. |
FDA Determined Cause 2 | Other |
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. |
Quantity in Commerce | 925 units |
Distribution | Nationwide; 17 international: Switzerland, Dubai, Brazil, Canada, South Africa, Australia, Belgium, Spain, Thailand Turkey, Costa Rica, Denmark, India, Italy, and France. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JDI
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