Recall Z-0244-2022— Laboratoires Bodycad, Inc.
Class II · Terminated
Class II FDA medical device recall by Laboratoires Bodycad, Inc., initiated 2021-07-02, terminated 2023-01-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.. Reason: There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use..
- Recalling firm
- Laboratoires Bodycad, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-02
- Terminated
- 2023-01-04
- Firm location
- Quebec, N/A, Canada
Product description
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
Reason for recall
There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.