Recall Z-0572-2025 ยท LXH Orthopedic Manual Surgical Instrument
Gauthier Biomedical, Inc.
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
| Date | Nov 27, 2024 (initiated Nov 11, 2024) |
| Status | Open, Classified |
| 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 i |
| Quantity | 160 units |
| Distribution | US Nationwide distribution in the state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.