TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Summary
The FDA issued a Class II for TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) by Gauthier Biomedical, Inc.. Reason: An out of specification component may result in the device exhibiting torque output higher than the design specification..
Details
Source
Device Recall
External ID
Z-0572-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Lot/Code Info: Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
Quantity Affected: 160 units
Reason for Recall
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Distribution
US Nationwide distribution in the state of MA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-11
Company
Grafton, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gauthier Biomedical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gauthier Biomedical, Inc. have FDA actions?
This is the only FDA action we have on record for Gauthier Biomedical, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0572-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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