← FDA ENFORCEMENT
Z-1629-2026Class II
Orthalign, Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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 & QualificationReason 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
2026-10-21Class IIZydus Pharmaceuticals (USA) Inc2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation2026-10-14Class IICipla USA, Inc.
See all Validation & Qualification recalls →Data: U.S. FDA. 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. Open the enforcement explorer →