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Smith & Nephew, Inc. · Model 120709 · UDI-DI 03596010061140
LZN
Prescription
1
510(k) clearances
212
Adverse events (4 deaths)
8
Recalls
52
Facilities
Description
ACETABULAR CEMENT RESTRICTOR POLYETHYLENE LARGE 38.10MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-07 | Stryker Corporation | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of funct |
| 2023-08-07 | Stryker Corporation | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of funct |
| 2023-08-07 | Stryker Corporation | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of funct |
| 2023-08-07 | Stryker Corporation | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of funct |
| 2023-08-07 | Stryker Corporation | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of funct |
| 2023-08-07 | Stryker Corporation | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of funct |
| 2023-08-07 | Stryker Corporation | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of funct |
| 2022-12-19 | Depuy Ireland UC | All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA r |
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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.