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Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF… recallZ-0389-2010 · Smith & Nephew Inc · initiated Jan 23, 2009

Terminated All recalls posted in November 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0389-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 23, 2009
Posted by the FDA
Nov 20, 2009
Recalling firm
Smith & Nephew Inc
Quantity
925 units
Product code
JDI
FDA submissions
K030766
Distribution
Nationwide; 17 international: Switzerland, Dubai, Brazil, Canada, South Africa, Australia, Belgium, Spain, Thailand Turkey, Costa Rica, Denmark, India, Italy, and France.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

12 devices cleared under K030766 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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