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6.5MM Flexible Reamer
CURVAFIX, INC. · Model CFR-065 · UDI-DI 10855068008263
HTO
Prescription
10
510(k) clearances
29,419
Adverse events (5 deaths)
83
Recalls
355
Facilities
Description
A surgical drilling instrument (6.5mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
| 2022-12-07 | Zimmer, Inc. | Two planers were found to be unusable during sawbones shoulder training. |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
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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.