Gauthier Biomedical, Inc. is recalling 160 TriALTIS Torque Limiters (Model 5161-00-5048) because a component may be out of specification. This defect can cause the tool to apply more force (torque) than intended during use. No incidents or injuries have been reported at this time.
The device may output torque higher than its design specification, which could lead to device failure or patient injury during medical procedures.
Internal Reference: G919509
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.