DePuy Orthopaedics, Inc. recalls TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Ins
Recalled Product
TRUMATCH CT FEM CUT TIB PIN 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: 420907
Hazard / Issue
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.
Issued by
FDA
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