| Class 2 Device Recall Bodycad |  |
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
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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
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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 |
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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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