Orthalign recalls Drill Plate model REF:402:566 with potential bone cut risk due to manufacturing defect. Affected units include specific lot numbers and UDI codes. Consumers should contact Orthalign for details.
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Orthalign is recalling Drill Plates with a specific model and lot number because they may cause bone cuts larger than 2.8448mm. This defect could lead to serious injury if the drill plate is used as intended.
Drill plates made outside specifications can cut bone tissue beyond 2.8448mm. This risk occurs when the drill plate is used in medical procedures to adjust knee implants, potentially causing severe injury.
Orthalign Drill Plate users with the model REF:402566, lot number 25091103BB, or UDI code 00810832032427 are affected. People using these plates for medical knee procedures are at highest risk.
Check for the model name 'Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5' and lot number 25091103BB or UDI code 00810832032427 on the product packaging.
Immediately stop using the Drill Plate if it matches the recalled model, lot number, or UDI code.
The recalled model is Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566.
Check for lot number 25091103BB or UDI code 00810832032427 on the product packaging.
Immediately stop using it and contact Orthalign for further instructions.
We’ve drafted a message you can send Orthalign to request your refund or repair — edit it as you like.
Subject: Recall Z-1629-2026 — Orthalign Orthalign Hello, I own a Orthalign that is covered by recall Z-1629-2026 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.
