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RIVA Posterior Fixation System
XENIX MEDICAL LLC · Model FG1-53-065090 · UDI-DI 00840493412535
1
510(k) clearances
52
Adverse events
3
Recalls
95
Facilities
Description
BONE SCREW, CANNULATED, CORTICAL CANCELLOUS FENESTRATED, 6.5mm X 90mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-09 | Karl Storz Endoscopy | The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level. |
| 2017-10-10 | Karl Storz Endoscopy | The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product. |
| 2013-07-15 | DeRoyal Industries Inc | DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which |
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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.