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gSource
GSOURCE LLC · Model gS 61.6505 · UDI-DI 00840314232328
4
510(k) clearances
0
Adverse events
4
Recalls
147
Facilities
Description
Miller Colburn Bone File #5 DE 7 1/2", 6mm/5.5mm str, downcutting, oval, serr
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
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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.