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TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number… recallZ-0572-2025 · Gauthier Biomedical, Inc. · initiated Nov 11, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Gauthier Biomedical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

An out of specification component may result in the device exhibiting torque output higher than the design specification.

FDA root cause category: Process change control

What the company is doing

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

Recall details

Recall number
Z-0572-2025
Status
Open, Classified
Initiated by the company
Nov 11, 2024
Posted by the FDA
Nov 27, 2024
Recalling firm
Gauthier Biomedical, Inc.
Quantity
160 units
Product code
LXH
Distribution
US Nationwide distribution in the state of MA.

Product description

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

Code information (models, lots, serial numbers)

Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page