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U.S. Department of Health and Human Services

Class 2 Device Recall Bodycad

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  Class 2 Device Recall Bodycad see related information
Date Initiated by Firm July 02, 2021
Create Date November 17, 2021
Recall Status1 Terminated 3 on January 04, 2023
Recall Number Z-0244-2022
Recall Event ID 88878
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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.
Code Information Torque Limiting Adaptor - Lot number SB000430.  Fine osteotomy tray - Lot numbers SB000251, SB000252, SB000253, SB000254, SB000259, SB000261, SB000263, SB000264, SB000272, and SB000273.
Recalling Firm/
Manufacturer		 Laboratoires Bodycad, Inc.
2035 Du Haut-Bord St
Quebec Canada
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 10 in the U.S.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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