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Medium risk Medical DevicesClass II

Orthalign Drill Plate Lantern Knee System Recall

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

Updated February 10, 2026

Orthalign's Drill Plate component for the Lantern Knee System can be manufactured out of specification, causing bone cuts larger than intended during surgery. This could affect surgical accuracy and patient outcomes.

Is the Orthalign, Inc recalled? Yes. This product was recalled by FDA on February 10, 2026. Details below.

What is recalled

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1-5, Reference Number 402566, which is a component of the Lantern Knee System.

Am I affected

You are affected if your healthcare facility or surgical center has this drill plate component in inventory. Check for Reference Number 402566 on the packaging or product documentation.

What to do right now

If you are a healthcare provider or facility using this device, stop using affected units and contact Orthalign, Inc. directly to identify which products are affected and arrange for replacement or inspection.

The hazard

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

Brands affected

Orthalign, Inc
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1629-2026
Classification
Class II
Recalled
February 10, 2026
Read the official notice

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