Home › SYNTHES (U.S.A.) LP › NA
NA
SYNTHES (U.S.A.) LP · Model 02.222.138 · UDI-DI 10886982056009
1
510(k) clearances
876
Adverse events (2 deaths)
2
Recalls
14
Facilities
Description
5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/38MM
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.