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Synthes GmbH · Model OCM7-07SD · UDI-DI 00845384017622
1
510(k) clearances
2,714
Adverse events (3 deaths)
4
Recalls
87
Facilities
Description
0.7 mm Diamond Ball, 7.3 cm. Use with OCM Attachment.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-05 | Medtronic Xomed, Inc. | Product was distributed past expiration date. |
| 2021-08-31 | Medtronic Xomed, Inc. | There was an increase in complaints related to tip breaks and wobble/vibration. |
| 2017-08-03 | Gyrus ACMI, Inc. | "Chattering" when cutting burrs are used in bone. |
| 2002-01-25 | Medtronic Xomed, Inc. | Product packaging pouches may be open thereby compomising the sterile barrier. |
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