Class 2 Device Recall Infinity ACL Tibial Elbow and Tip Guides

• Date Initiated by Firm: November 12, 2020
• Create Date: December 21, 2020
• Recall Status: Terminated on April 05, 2024
• Recall Number: Z-0651-2021
• Recall Event ID: 86746
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
• Code Information: Lot Codes: 201941AE 201946AF 202006AF 202010AF 202015AF 202019AF 202023AF
• Recalling Firm/ Manufacturer: ConMed Corporation; 525 French Rd; Utica NY 13502-5945
• Manufacturer Reason for Recall: Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
• FDA Determined Cause: Process control
• Action: Conmed issued Urgent Medical Device Recall lettersvia USPS First Class November 12, 2020 stating reason for recall, health risk and action to take: Please review your inventory for any of the devices with the affected lot codes listed on Attachment I. We ask that you contact all those departments within your facility and all other facilities that may have received affected products from you. It is imperative that all end users of these devices receive this notice and respond immediately. If you HAVE inventory of any of unused devices from the affected lot codes still in their original intact cartons listed on Attachment I, please complete the business reply form (Attachment II) and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac Return via: UPS Account # W5Y243 (no charge to your facility) Step 2b: If you HAVE inventory of any used devices from the affected lot codes listed on Attachment I, you may return them using the following method: a) Please clean, disinfect and sterilize the device the device following the directions for Cleaning, Disinfection, and Sterilization Information found in the Infinity" Drill Guide System Instructions for Use, P000009343 (https://www.conmed.com/en/customer-service/catalogs-and-ifus) on pages 4-6 of the English language section or the appropriate translation. b) Place the cleaned and sterilized device in a sterile wrap and insert this in a zip lock bag. Label the bag with the catalog number and lot code. Please mark the bag Used Device. c) Please complete the business reply form (Attachment II) and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac Return via: UPS Account # W5Y243 (no charge to your facility) Step 2c: If you DO NOT HAVE any affected devices to return, please complete the business reply form (Attachment II), indicating you have no devices and return by one of the means listed below: 1. Email to:
• Quantity in Commerce: 95 total: 20 units US and 75 units OUS
• Distribution: Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
• 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.