DePuy recalls TRUMATCH CT Pin Guide Kit R due to a software error that may cause hip, knee or ankle misalignment during joint replacement surgery. Affected kits have specific part numbers and GTINs.
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 Pin Guide Kit R products because of a software error that could cause limb misalignment during hip, knee or ankle surgery. This risks improper joint replacement positioning and may lead to complications.
The Fast3D Segmentation software has a coding error that may cause the three required images (hip, knee, ankle) to misalign during scanning. This misalignment could lead to incorrect bone marking and improper joint replacement positioning.
Surgical teams using DePuy TRUMATCH CT Pin Guide Kit R products for joint replacements are affected. Patients undergoing hip, knee, or ankle surgery with these kits face the highest risk.
Check for part numbers 420579 or GTINs 27929, 27855, 27667, 27591, 27521, 27332 on the kit packaging. These products were sold with the GTIN 10603295430803.
Identify the part number (420579) or GTIN (27929, 27855, 27667, 27591, 27521, 27332) on the kit packaging.
The Fast3D Segmentation software has a coding error that may cause the hip, knee, and ankle images to misalign during scanning, potentially leading to limb misalignment.
Misaligned images could result in incorrect bone marking and improper joint replacement positioning, risking surgical complications.
Check the product details for part number 420579 or GTINs 27929, 27855, 27667, 27591, 27521, 27332. Contact DePuy for guidance.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-2395-2021 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-2395-2021 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.