Smith & Nephew Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Smith & Nephew Inc
Lot Codes / Batch Numbers
Lot Numbers: 08LM01326, 08LM01327, 08LM02210
Products Sold
Lot Numbers: 08LM01326, 08LM01327, 08LM02210
Smith & Nephew Inc is recalling Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for u due to 46 mm Femoral head was mismarked and packaged as being 45 mm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
46 mm Femoral head was mismarked and packaged as being 45 mm
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, MI
Page updated: Jan 10, 2026