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U.S. Department of Health and Human Services

Class 2 Device Recall TriALTIS TORQUE LIMITER

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 Class 2 Device Recall TriALTIS TORQUE LIMITERsee related information
Date Initiated by FirmNovember 11, 2024
Date PostedNovember 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0572-2025
Recall Event ID 95746
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductTriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Code Information Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
Recalling Firm/
Manufacturer
Gauthier Biomedical, Inc.
2221 Washington St
Grafton WI 53024-9506
For Additional Information ContactHeidi Wright
1-262-5460010 Ext. 9045
Manufacturer Reason
for Recall
An out of specification component may result in the device exhibiting torque output higher than the design specification.
FDA Determined
Cause 2
Process change control
ActionA Medical Device Recall (Removal) notification letter dated 11/11/24 was sent to the customer. Please Take the Following Steps: 1. Examine your inventory to determine if you have the affected lots and quarantine them immediately. DO NOT USE THE AFFECTED INSTRUMENTS. 2. Follow standard product return practices by contacting Heidi Wright at heidi.wright@gauthierbiomedical.com to issue an RMA number and coordinate the return of the affected product(s) to the following address: ATTN: Heidi Wright Gauthier Biomedical, Inc. 2221 Washington Street Grafton, WI 53024 Note: If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on this page of the notification. 3. Review, complete, sign and return the attached Verification Form to Heidi Wright at heidi.wright@gauthierbiomedical.com within five (5) business days of receipt of this notification. Please include in the email subject: CA 24-010. 4. Please complete the attached Verification Form even if you do not have the affected product lots on hand. 5. Forward this notice to anyone in your facility that needs to be informed (e.g., those who manage transport, store, stock, or use the affected products). 6. If any of the affected product lots have been forwarded to another facility, contact that facility and provide them with this notice. 7. Post a copy of this notice in a visible area for awareness and keep a copy for your records. 8. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reportingprogram/reporting-serious-problems-fda. This medical device recall (removal) has been reported to the relevant health authorities. If you have any questions, please contact Heidi Wright, Quality Manager at Gauth
Quantity in Commerce160 units
DistributionUS Nationwide distribution in the state of MA.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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