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OSUNG MND
OSUNG MND Co., Ltd. · Model BF22 · UDI-DI 08800075612892
4
510(k) clearances
0
Adverse events
4
Recalls
146
Facilities
Description
A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
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.