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RIVA Posterior Fixation System
XENIX MEDICAL LLC · Model FG1-A3-000050 · UDI-DI 00818345029583
3
510(k) clearances
9
Adverse events
2
Recalls
22
Facilities
Description
Set Screw Inserter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-05-10 | Zimmer Biomet Spine Inc. | Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closur |
| 2015-01-13 | Medtronic Sofamor Danek USA Inc | The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments |
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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.