Orthalign recalls Drill Plate model REF:402567 for bone cuts exceeding 2.8448mm due to manufacturing defects. Affected units sold with specific lot numbers.
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Orthalign is recalling Drill Plates with model REF:402567 because they can cause bone cuts larger than 2.8448mm. This risk exists in normal use due to manufacturing defects.
Drill plates made outside specifications can cut bone tissue beyond 2.8448mm. This risk occurs during normal use when the plate is being adjusted or installed.
Orthalign Drill Plate users with model REF:4025:402567 and lot number 25092204BB are affected. People using these plates for orthopedic procedures are at highest risk.
Check for model REF:402567 and lot number 25092204BB on the Drill Plate. The product is part of the Lantern Knee System for orthopedic use.
Immediately stop using the Drill Plate if it has model REF:402567 and lot number 25092204BB.
The recalled Drill Plate model is REF:402567.
Lot number 25092204BB is affected.
Check for model REF:402567 and lot number 25092204BB on the Drill Plate, which is part of the Lantern Knee System.
We’ve drafted a message you can send Orthalign to request your refund or repair — edit it as you like.
Subject: Recall Z-1630-2026 — Orthalign Orthalign Hello, I own a Orthalign that is covered by recall Z-1630-2026 from Orthalign. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
