Z-0244-2022Class II

Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine...

Name: Z-0244-2022 Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine...
Creator: Laboratoires Bodycad, Inc.
Published: 2021-07-02
License: https://open.fda.gov/license/

Bodycad Laboratories, Inc. / initiated 2021-07-02 / Terminated / root cause: manufacturing process

FDA source

Laboratoires Bodycad, Inc. began a recall of Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray... on 2021-07-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0244-2022
Classification: Class II
Status: Terminated
Initiated: 2021-07-02
Posted: 2021-11-17
Terminated: 2023-01-04
Recalling firm: Bodycad Laboratories, Inc.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Torque Limiting Adaptor - Lot number SB000430. Fine osteotomy tray - Lot numbers SB000251, SB000252, SB000253, SB000254, SB000259, SB000261, SB000263, SB000264, SB000272, and SB000273.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0244-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0244-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-17

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)