DePuy recalls TRUMATCH CT Cut Guide Kit L patient-specific surgical instruments due to a software error that may cause hip, knee or ankle misalignment during joint replacement surgery. Affected units 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 Cut Guide Kit L surgical instruments because a software error could cause misalignment of limbs during hip, knee or ankle joint replacement surgery. This risks improper surgical outcomes and potential complications.
A coding error in the Fast3D Segmentation software causes the three required images (hip, knee, ankle) to misalign during scanning. This misalignment may lead to incorrect anatomical landmark placement, potentially causing limb malalignment during surgery.
Surgical teams using DePuy TRUMATCH CT Cut Guide Kit L instruments for joint replacement procedures. Patients undergoing hip, knee, or ankle surgery with these instruments are at risk of improper limb alignment.
Check for part numbers 420915 or GTINs 28289, 28247, 27876, 27432, 27613. These instruments were sold with the OUS (outside the U.S.) designation.
Verify your instrument's part number or GTIN to confirm if it's affected by this recall.
Reach out to DePuy Orthopaedics for guidance on next steps if you have the recalled instruments.
The software error causes hip, knee, and ankle images to misalign during scanning, which may lead to improper limb alignment during surgery.
Part number 420915 and GTINs 28289, 28247, 27876, 27432, 27613.
No immediate stop is required, but you should check if your instruments are affected and 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-2398-2021 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-2398-2021 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.
