DePuy recalls TruMatch CT Pin Guide Fem R surgical instruments due to a software error that may cause hip, knee, and ankle misalignment during joint replacement procedures. 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 Tru:Match CT Pin Guide Fem R surgical instruments because a software error could cause limb misalignment during hip, knee, or ankle joint replacement surgery. This risk affects patients undergoing these procedures with the recalled instruments.
The Fast3D Segmentation software has a coding error that can cause the hip, knee, and ankle images to misalign during the scanning process. This misalignment might lead to incorrect placement of joint replacement components, potentially causing limb misalignment.
Surgical teams using the recalled TruMatch CT Pin Guide Fem R instruments for joint replacement procedures are most at risk. Patients undergoing surgery with these instruments may experience misalignment of their limbs.
Check for part number 420581 and lot numbers 28206 or 27983 on the instrument packaging. The product was sold with GTIN 10603295430773.
Verify the part number (420581) and lot numbers (28206, 27983) on the instrument packaging.
The Fast3D Segmentation software has a coding error that may cause hip, knee, and ankle images to misalign during scanning, potentially leading to limb misalignment.
Check for part number 420581 and lot numbers 28206 or 27983 on the instrument packaging. The product was sold with GTIN 10603295430773.
The recall does not specify a stop-use instruction; you should check the instrument details to confirm if it is affected.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-2396-2021 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-2396-2021 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.
