Recall Z-2396-2021 · NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

DePuy Orthopaedics, Inc.

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

Date	Aug 10, 2021
Status	Terminated
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.
Root cause	Software Design Change
Action	Depuy issued Urgent Medical Device Recall (Removal) Letter on 8/10/21. Letter states reson for recall, health risk and action take: 1. Examine your inventory immediately to determine if you have the subject lot and quarantine the product. DO NOT USE THE PRODUCT. The surgical plan associated with the cases in Table 1 should not be used with conventional instruments. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return/credits of any affected devices or contact TruMatch Personalized Solutions Customer Support at 1-800-689-0746 / trumatchsupport@its.jnj.com between 7am and 7pm
Quantity	2 cases (1 case)
Distribution	Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.