Class 2 Device Recall TRUMATCH CT CUT GUIDE KIT L

• Date Initiated by Firm: August 10, 2021
• Create Date: September 01, 2021
• Recall Status: Terminated on May 17, 2023
• Recall Number: Z-2398-2021
• Recall Event ID: 88522
• PMA Number: P830055
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
• Product: TRUMATCH CT CUT 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: 420915
• Code Information: Lot number/ GTIN: 28289, 28247, 27876, 27432, 27613 (OUS) GTIN: 10603295384854
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: 574-267-8143
• Manufacturer Reason for Recall: 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 Determined 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 EST. 3. Review, complete, sign, and return the attached business response form (page 4 of this letter) to OneMD-Field-Actions@its.jnj.com within 3 business days of receipt of this notification. Please include in the email subject: FA 2000415: 2021 - TruMatch Personalized Solutions 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the devices subject to this action). 5. If any of the subject lot has been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. This medical device product recall has been reported to health authorities. We apologize for the inconvenience that this recall may cause and appreciate your cooperation with our request. Should you have any inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
• Quantity in Commerce: 5 cases ( 1/cs)
• Distribution: Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NJL and Original Applicant = DEPUY, INC.