TriALTIS Torque Limiter Ratchet Recalled for Excessive Torque Output
Gauthier Biomedical is recalling the TriALTIS TORQUE LIMITER due to an out-of-specification component that may cause the device to produce higher torque output than intended. The recall affects 160 units.
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 FDA Class II recall addresses a risk-of-harm medical device with no reported illnesses or injuries. The defect could compromise device performance in surgical applications, meeting the criterion for High severity.
Plain-English summary
Gauthier Biomedical, Inc. is recalling the TriALTIS TORQUE LIMITER, RATCHET, Model 5161-00-5048 (UDI-DI 00858325005688). This precision torque control device is used in medical and surgical applications.
An out-of-specification component has been identified in the device. This defect may cause the device to produce torque output higher than the design specification of 11.3 Nm, which could affect the accuracy of procedures where precise torque control is required.
The recall affects 160 units bearing Lot Numbers GB153869 and GB156110. Affected units were distributed in the United States.
If you have this device, discontinue use and contact Gauthier Biomedical, Inc. for instructions on replacement or corrective action. The FDA is overseeing this Class II recall.
The recalled product
- Product
- TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
- Manufacturer
- Gauthier Biomedical, Inc.
- Category
- Medical Device — Surgical Tools
- Affected units
- 160
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 (3)
- Model No 5161-00-5048
- UDI-DI 00858325005688
- Lot Numbers: GB153869 and GB156110
Distribution
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