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Spinal System
BIOMET SPINE LLC · Model 132M1001 · UDI-DI 00880304836976
HXL
Prescription
3
510(k) clearances
74
Adverse events
1
Recalls
202
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-21 | Implant Resource Inc | Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected |
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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.