Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant a
Summary
The FDA issued a Class II for Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component by Laboratoires Bodycad, Inc.. 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 vali.
Details
Source
Device Recall
External ID
Z-0244-2022
Action Date
2021-11-24
Status
Terminated
Category
device
Product 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.
Lot/Code Info: Torque Limiting Adaptor - Lot number SB000430. Fine osteotomy tray - Lot numbers SB000251, SB000252, SB000253, SB000254, SB000259, SB000261, SB000263, SB000264, SB000272, and SB000273.
Quantity Affected: 10 in the U.S.
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-02
Company
Quebec, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Laboratoires Bodycad, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Laboratoires Bodycad, Inc. have FDA actions?
This is the only FDA action we have on record for Laboratoires Bodycad, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0244-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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