DePuy Orthopaedics recalls TRUMATCH CT FEM CUT TIB PIN R patient-specific surgical instruments due to a software error that may cause limb misalignment during hip, knee, and ankle scans.
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 Orthopaedics is recalling TRUMATCH CT FEM CUT TIB PIN R patient-specific surgical instruments because a software error during CT scanning could cause limb misalignment. This risk affects patients undergoing joint replacement surgery.
A coding error in the Fast3D Segmentation software may cause the hip, knee, and ankle images to misalign during CT scanning. This misalignment could lead to improper bone positioning during joint replacement surgery.
Patients who have received TRUMATCH CT FEM CUT TIB PIN R instruments for joint replacement surgery are most at risk. The recall applies to specific surgical instruments used by orthopedic surgeons.
Check for the product name 'TRUMATCH CT FEM CUT TIB PIN R' with part number 420907 or lot numbers 27975 and 27470. The instruments are used in joint replacement surgery.
Your surgeon will provide instructions on whether to continue using the instruments or if a replacement is needed.
The recall is for a software error that may cause limb misalignment during surgery, but the risk is low and does not cause immediate injury.
Check for the product name 'TRUMATCH CT FEM CUT TIB PIN R' with part number 420907 or lot numbers 27975 and 27470.
The recall does not require immediate discontinuation; your surgeon will advise based on your specific case.
We’ve drafted a message you can send DePuy Orthopaedics to request your refund or repair — edit it as you like.
Subject: Recall Z-2397-2021 — DePuy Orthopaedics DePuy Orthopaedics Hello, I own a DePuy Orthopaedics that is covered by recall Z-2397-2021 from DePuy Orthopaedics. 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.