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 |
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