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Orthalign, Inc: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Medical DevicesSource: FDA (device) · Date: 2026-04-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Orthalign, Inc
Product
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Reason / hazard
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of UT.
Recall initiated
2026-02-10
Code info
Lot # 25091103BB/ UDI: 00810832032427
Product quantity
7 units
Voluntary mandated
Voluntary: Firm initiated
City
Aliso Viejo
State
CA
Country
United States
Event id
98516
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