Recall – Incorrect landmark locations with surgical positioning software

Company: DePuy Orthopaedics, Inc.
Date of Enforcement Report: 9/8/2021
Class II

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

Recall Number: Z-2394-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

DePuy Orthopaedics, Inc. on 8/10/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

4 cases (1/case)

DISTRIBUTION

U.S. Nationwide and International

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