Bodycad Torque Limiting Adaptor Recalled for Breakage Risk
Laboratoires Bodycad is recalling its Torque Limiting Adaptor AO Connect due to risk of breakage if used counterclockwise and lack of validation for power tool use. Approximately 10 units were distributed to facilities in Colorado, Michigan, and New York.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported incidents of injury or hospitalization. The hazard represents a risk of equipment failure under specific use conditions, making this a risk-of-harm product without realized injury.
Plain-English summary
Laboratoires Bodycad, Inc. is recalling the Torque Limiting Adaptor AO Connect (part #027-203), a reusable component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray (part #025-004). The recall affects approximately 10 units that were distributed in the United States to facilities in Colorado, Michigan, and New York.
The adaptor poses a risk of breakage if used counterclockwise. Additionally, the adaptor must not be used with power tools because there is no test data validating this use.
Healthcare providers who have this product should discontinue use immediately and contact Laboratoires Bodycad, Inc. for return or replacement instructions. Patients who believe they may have received this product should contact their healthcare provider.
The recalled product
- 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.
- Manufacturer
- Laboratoires Bodycad, Inc.
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- SB000252
- SB000253
- SB000254
- SB000259
- SB000261
- SB000263
- SB000264
- SB000272
- and SB000273.
Distribution
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