FDA Medical Device Recalls (openFDA)
Gauthier Biomedical, Inc.: TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
- Recall number
- Z-0572-2025
- Recalling firm
- Gauthier Biomedical, Inc.
- Product
- TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
- Status
- Open, Classified
- Initiated
- 2024-11-11
- Posted
- 2024-11-27
- Terminated
- not on file
- Reason
- An out of specification component may result in the device exhibiting torque output higher than the design specification.
- 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 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
- 160 units
- Distribution
- US Nationwide distribution in the state of MA.
- Lot, serial or model codes
- Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3010938185
- Firm city
- Grafton
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28