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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0244-2022
Event ID88878
Event DescriptionTorque 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 TypeDevices
DistributionDistribution was made to CO, MI, and NY. Foreign distribution was made to Canada and the United Kingdom. There was no military/government distribution.
Quantity10 in the U.S.
Recall ReasonThere 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 Classification20211124
Device Code InfoTorque Limiting Adaptor - Lot number SB000430. Fine osteotomy tray - Lot numbers SB000251, SB000252, SB000253, SB000254, SB000259, SB000261, SB000263, SB000264, SB000272, and SB000273.
Center Classification Date20211117
Recall Initiation Date20210702
Recalling FirmLaboratoires Bodycad, Inc.
Initial Notification Letter
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