DePuy recalls TRUMATCH CT Cut Guide Kit R patient-specific surgical instruments due to a software error that may cause hip, knee, and ankle misalignment during surgery. Affected units have specific part numbers and lot codes.
Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
DePuy is recalling TRUMATCH CT Cut Guide Kit R surgical instruments because a software error can cause misalignment of limbs during hip, knee, or ankle surgery. This could lead to improper joint replacement positioning if the images aren't aligned correctly.
The Fast3D Segmentation software has a coding error that may cause the hip, knee, and ankle images to misalign during the scanning process. This misalignment could result in incorrect bone marking and improper joint replacement positioning.
Surgical patients and their healthcare providers who use the TRUMATCH CT Cut Guide Kit R for joint replacement procedures. The risk is highest for those using the specific part numbers and lot codes listed in the recall.
Check the product's part number (420916) and lot numbers (28226, 28135, 27612, 27544, 27431, 27407, 26970) or GTINs (10603295384861). The kit is sold under the brand DePuy for surgical use.
Identify the part number (420916) and lot numbers (28226, 28135, 27612, 27544, 27431, 27407, 26970) or GTIN (10603295384861) to confirm if the product is affected.
The recall is for a software error that could cause limb misalignment during surgery, but it does not indicate immediate risk of serious injury. The hazard level is low risk.
Check the product's part number and lot numbers to see if it's affected. If it is, contact DePuy for guidance.
Affected products have part number 420916 and lot numbers 28226, 28135, 27612, 27544, 27431, 27407, or 26970, or GTIN 10603295384861.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-2399-2021 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-2399-2021 from DePuy. 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.
