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MEDTRONIC SOFAMOR DANEK, INC. · Model EX0118044 · UDI-DI 00763000108366
HWN
Prescription
4
510(k) clearances
822
Adverse events
9
Recalls
167
Facilities
Description
ARM EX0118044 5.5/6.0 DISTRACTOR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
| 2010-02-16 | Zimmer Inc. | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential |
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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.