DePuy recalls TRUMATCH CT PIN GUIDE KIT L due to a software error that may cause hip, knee, or ankle misalignment during joint replacement surgery. Affected units have specific part and lot numbers.
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 L surgical instruments because a software error could cause misalignment of limbs during hip, knee, or ankle joint replacements. This risks improper surgical outcomes if the software fails to align the three required images.
A coding error in the Fast3D Segmentation software causes the three images (hip, knee, ankle) to misalign during scanning. This misalignment could lead to incorrect bone marking and improper joint replacement positioning.
Surgical teams using the TRUMATCH CT PIN GUIDE KIT L for joint replacements are most at risk. Patients scheduled for hip, knee, or ankle surgery using this kit may be affected.
Check for part number 420578 and lot numbers 27932, 27806, 27515, or 27466 on the kit. The kit was sold with GTIN 10603295430797.
Verify the part number (420578) and lot numbers (27932, 27806, 27515, 27466) on the kit.
A coding error in the Fast3D Segmentation software causes the three images (hip, knee, ankle) to misalign during scanning, potentially leading to limb misalignment.
Misaligned images could result in incorrect bone marking and improper joint replacement positioning, risking surgical outcomes.
Check the part number and lot numbers on the kit. If affected, 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-2394-2021 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-2394-2021 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.