medical Class II Updated 2021-09-08

DePuy Orthopaedics, Inc. recalls TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instr

Recalled Product

TRUMATCH CT CUT GUIDE KIT 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: 420916

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

Affected States: CA, CO, FL, IL, IN, NY, MI, MN, TX, WA

Lot/Code Info: Lot number/ GTIN: 28226, 28135, 27612, 27544, 27431, 27407, 26970 OUS: 27476, 27779 GTIN: 10603295384861;

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