Laboratoires Bodycad, Inc. Recall 88878
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.
Laboratoires Bodycad, Inc. Recall 88878 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0244-2022 |
| Event ID | 88878 |
| Event 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. |
| Product Type | Devices |
| Distribution | Distribution was made to CO, MI, and NY. Foreign distribution was made to Canada and the United Kingdom. There was no military/government distribution. |
| Quantity | 10 in the U.S. |
| Recall 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. |
| Device Classification | 20211124 |
| Device Code Info | Torque Limiting Adaptor - Lot number SB000430. Fine osteotomy tray - Lot numbers SB000251, SB000252, SB000253, SB000254, SB000259, SB000261, SB000263, SB000264, SB000272, and SB000273. |
| Center Classification Date | 20211117 |
| Recall Initiation Date | 20210702 |
| Recalling Firm | Laboratoires Bodycad, Inc. |
| Initial Notification | Letter |
| Similar To |