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Synthes GmbH · Model 02.231.660 · UDI-DI 10886982062871
1
510(k) clearances
876
Adverse events (2 deaths)
2
Recalls
14
Facilities
Description
5.0MM CANNULATED VA LOCKING SCREW/60MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-02-05 | Synthes, Inc. | Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 |
| 2013-05-29 | Synthes USA HQ, Inc. | A plate was inadvertently released to a sales consultant that was restricted for sale. |
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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.