CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
TriALTIS Torque Limiter, Ratchet, 3 Nm recalled by Gauthier Biomedical
Gauthier Biomedical is recalling TriALTIS Torque Limiter, Ratchet, 3 Nm, distributed nationwide in the US. The recall was initiated on 11 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0572-2025
- FDA event ID
- 95746
- Recalling firm
- Gauthier Biomedical, Grafton, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Nov 2024
- FDA classified
- 27 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 11 Nov 2024 | Recall initiated by company | |
| 27 Nov 2024 | Classified by FDA | +16 days |
| 4 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Where it was distributed
US Nationwide distribution in the state of MA.
Questions about this recall
Is TriALTIS Torque Limiter, Ratchet, 3 Nm recalled?
Yes. Gauthier Biomedical recalled TriALTIS Torque Limiter, Ratchet, 3 Nm on 11 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0572-2025.
Why was it recalled?
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Which lots are affected?
Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
Where was it sold?
US Nationwide distribution in the state of MA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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