Z-0572-2025Class II

TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)

Name: Z-0572-2025 TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Creator: Gauthier Biomedical, Inc.
Published: 2024-11-11
License: https://open.fda.gov/license/

Gauthier Biomedical, Inc. / initiated 2024-11-11 / Open, Classified / root cause: design

FDA source

Gauthier Biomedical, Inc. began a recall of TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) on 2024-11-11. FDA classified it as Class II and gives the reason as "An out of specification component may result in the device exhibiting torque output higher than the design specification". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0572-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-11
Posted: 2024-11-27
Recalling firm: Gauthier Biomedical, Inc.
Product: TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: An out of specification component may result in the device exhibiting torque output higher than the design specification.
Root cause tag: design
FDA root cause: Process change control
Action: A 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 [email protected] 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 [email protected] 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 commerce: 160 units
Distribution: US Nationwide distribution in the state of MA.
Product codes and lots: Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0572-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0572-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)