FDA Medical Device Recalls (openFDA)
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 number
- Z-2314-2009
- 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.
- Status
- Terminated
- Initiated
- 2009-01-12
- Posted
- 2009-09-24
- Terminated
- 2011-03-25
- Reason
- 46 mm Femoral head was mismarked and packaged as being 45 mm
- 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
- 10 units
- Distribution
- CA, FL, MI, and Canada
- Lot, serial or model codes
- Lot Numbers: 08LM01326, 08LM01327, 08LM02210
- 510(k) numbers
- ["K030766"]
- PMA numbers
- not on file
- Product code
- LZY
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28