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General Instruments
ALPHATEC SPINE, INC. · Model CI-10412-3010 · UDI-DI 00811801037795
HTF
Prescription
3
510(k) clearances
116
Adverse events (2 deaths)
2
Recalls
316
Facilities
Description
Flat Edge Cup Curette, Bayonet, Push, Large, Offset
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-12 | MEDLINE INDUSTRIES, LP - Northfield | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
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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.