Z-0389-2010

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

Name: Z-0389-2010 Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
Creator: Smith & Nephew Inc
Published: 2009-01-23
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-01-23 / Terminated

FDA source

Smith & Nephew Inc began a recall of Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116 on 2009-01-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0389-2010
Status: Terminated
Initiated: 2009-01-23
Posted: 2009-11-20
Terminated: 2012-02-07
Recalling firm: Smith & Nephew, Inc.
Product: Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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 root cause: 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.
Product codes and lots: 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

Product code JDI

K030766Class IIOxinium Femoral HeadsSmith & Nephew, Inc. / cleared 2003-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)