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LUX Expandable Interbody System
XENIX MEDICAL LLC · Model LE1-A6-001410 · UDI-DI 00840493416472
1
510(k) clearances
861
Adverse events
2
Recalls
266
Facilities
Description
Slap Hammer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-04-25 | SpineFrontier, Inc. | Malfunction of slap hammer. |
| 2008-05-07 | EBI, L.P. | Customer complaint received regarding the separation of the mallet handle during a medical procedure. |
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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.