Exact FDA event identifier

Event 95746

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: November 11, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Gauthier Biomedical, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0572-2025

Recall number: Z-0572-2025
Initiated: November 11, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Gauthier Biomedical, Inc.
Quantity: 160 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.