Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith &… recallZ-2314-2009 · Smith & Nephew Inc · initiated Jan 12, 2009
Terminated All recalls posted in September 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
46 mm Femoral head was mismarked and packaged as being 45 mm
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2314-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 12, 2009
- Posted by the FDA
- Sep 24, 2009
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 10 units
- Product code
- LZY
- FDA submissions
- K030766
- Distribution
- CA, FL, MI, and Canada
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers: 08LM01326, 08LM01327, 08LM02210
Other devices under the same FDA submission
12 devices cleared under K030766 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OXINIUM 71343600Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented81 reports
- OXINIUM 71343200Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented58 reports
- OXINIUM 71343604Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented53 reports
- OXINIUM 71343603Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented41 reports
- OXINIUM 71343204Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented38 reports
- OXINIUM 71342800Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented35 reports
- OXINIUM 71343608Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented33 reports
- OXINIUM 71342804Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented29 reports
- OXINIUM 71343203Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented28 reports
- OXINIUM 71343208Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented22 reports
- OXINIUM 71342808Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented15 reports
- OXINIUM 71342200Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented13 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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