Z-2314-2009

Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with...

Name: Z-2314-2009 Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with...
Creator: Smith & Nephew Inc
Published: 2009-01-12
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-01-12 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed... on 2009-01-12. The reason FDA records is "46 mm Femoral head was mismarked and packaged as being 45 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2314-2009
Status: Terminated
Initiated: 2009-01-12
Posted: 2009-09-24
Terminated: 2011-03-25
Recalling firm: Smith & Nephew, Inc.
Product: Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.
Product code: LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Reason for recall: 46 mm Femoral head was mismarked and packaged as being 45 mm
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All affected Smith & Nephew Sales Representatives were notified of problem and sent recall notice in overnight mail on 01/12/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/12/2009. They were instructed to immediately quarantine the product for return. The firm re-issued the letter on 04/06/2009 to address hazard to health. Contact Smith & Nephew, Inc at 1.901.399.6771 if there are any questions.
Quantity in commerce: 10 units
Distribution: CA, FL, MI, and Canada
Product codes and lots: Lot Numbers: 08LM01326, 08LM01327, 08LM02210

Product code LZY

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)