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SONTEC SPINAL FILE
SONTEC INSTRUMENTS, INC. · Model 345-216B · UDI-DI 00192896031456
EMI
Prescription
4
510(k) clearances
0
Adverse events
4
Recalls
148
Facilities
Description
SONTEC SPINAL FILE/RASPATORY STRAIGHT TIP BLACK PLASTIC HANDLE
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.