Monday, October 26, 2026 · Daily editionET --:--:--

Recall

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

Orthalign, Inc · 10 Feb 2026

Status
Recall open, classified
Why, in the FDA's words
“Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)”
Recall began
10 Feb 2026
Company
Orthalign, Inc
Device type
Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
Concerns
K200892

What it means

A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.

The record

The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.
FDA database