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DePuy Orthopaedics, Inc. recalls TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Recalled September 8, 2021 · FDA recall Z-2394-2021 · DePuy Orthopaedics
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. · FDA Class II
Units
4 cases (1/case)
Sold at
Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
Description
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.
Product
TRUMATCH CT PIN GUIDE KIT L- 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: 420578
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →