← FDA ENFORCEMENT
Z-1629-2026Class II

Orthalign, Inc

Recalling firm
Orthalign, Inc
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
US Nationwide distribution in the state of UT.
Firm state
CA
Product quantity
7 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

Product description

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

Code / lot info

Lot # 25091103BB/ UDI: 00810832032427

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.