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DYNAFIX VS OSTEOTOMY SYSTEM
Biomet Orthopedics, LLC · Model 10112P · UDI-DI 00880304491908
1
510(k) clearances
3
Adverse events
3
Recalls
7
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-11-22 | Stryker Howmedica Osteonics Corp. | The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation |
| 2004-09-07 | Stryker Howmedica Osteonics Corp. | Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees. |
| 2002-12-11 | Disc Orthopaedic Technologies Inc | The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure. |
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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.