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.
FDA Recall Z-0244-2022 · Posted None
Recalling FirmLaboratoires Bodycad, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2021-07-02
Date Terminated2023-01-04
Product Quantity10 in the U.S.
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.
Firm Action
The recalling firm issued an Advisory Notice Information dated 2020-06-30 on 7/2/2021 via email which explained the reason for recall and that they would be contacted as soon as possible to proceed with the exchange. On 9/24/2021, a Returned Goods Authorization Form was sent to the consignees so the adapter could be exchanged.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution was made to CO, MI, and NY. Foreign distribution was made to Canada and the United Kingdom. There was no military/government distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.