Gauthier Biomedical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0572-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 11, 2024

Date Posted: December 4, 2024

Recall Number: Z-0572-2025

Event ID: 95746

Reason for Recall:

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

Status: Ongoing

Product Quantity: 160 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of MA.

Voluntary or Mandated:

Voluntary: Firm initiated