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MotoBAND CP Reamer, 2.0mm
CROSSROADS EXTREMITY SYSTEMS · Model 130503 · UDI-DI 00815432028641
HTO
Prescription
10
510(k) clearances
29,528
Adverse events (5 deaths)
83
Recalls
358
Facilities
Description
The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws.
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.