FDA Medical Device Recalls (openFDA)
Laboratoires Bodycad, Inc.: 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.
- Recall number
- Z-0244-2022
- Recalling firm
- Laboratoires Bodycad, 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.
- Status
- Terminated
- Initiated
- 2021-07-02
- Posted
- not on file
- Terminated
- 2023-01-04
- 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 validating this use.
- 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
- 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.
- Lot, serial or model codes
- Torque Limiting Adaptor - Lot number SB000430. Fine osteotomy tray - Lot numbers SB000251, SB000252, SB000253, SB000254, SB000259, SB000261, SB000263, SB000264, SB000272, and SB000273.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3012086398
- Firm city
- Quebec
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28