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Tandem
Smith & Nephew, Inc. · Model 126648 · UDI-DI 03596010079770
LZY
Prescription
3
510(k) clearances
1,120
Adverse events (3 deaths)
3
Recalls
51
Facilities
Description
TANDEM UNIPOLAR HEAD 48MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-09 | BioPro, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is impla |
| 2022-05-18 | DePuy Orthopaedics, Inc. | The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clar |
| 2009-01-12 | Smith & Nephew Inc | 46 mm Femoral head was mismarked and packaged as being 45 mm |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.