FDAAugust 10, 2021device

TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420581

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

UPCs

10603295430773

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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