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CoFix implant loaner set
Paradigm Spine GmbH · Model 48-ls-cofix-imp · UDI-DI 04260636678929
PEK
Prescription
1
510(k) clearances
62
Adverse events
1
Recalls
78
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-29 | XTANT Medical | The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert. |
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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.