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Medtronic Reusable Instruments
MEDTRONIC SOFAMOR DANEK, INC. · Model X0797-035 · UDI-DI 00673978145372
HXQ
Prescription
0
510(k) clearances
13
Adverse events
1
Recalls
52
Facilities
Description
PROV CRIMP W/ MOD THUMB LEVER
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-09-26 | Biomet, Inc. | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. |
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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.