Recalls / —
—#83473
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.
- FDA product code
- LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K030766
- Affected lot / code info
- Lot Numbers: 08LM01326, 08LM01327, 08LM02210
Why it was recalled
46 mm Femoral head was mismarked and packaged as being 45 mm
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E. Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- CA, FL, MI, and Canada
Timeline
- Recall initiated
- 2009-01-12
- Posted by FDA
- 2009-09-24
- Terminated
- 2011-03-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #83473. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.