Class 2 Device Recall INFINITY_TRAY Custom Procedural Kit Canada

• Date Initiated by Firm: March 26, 2021
• Create Date: April 27, 2021
• Recall Status: Terminated on April 05, 2024
• Recall Number: Z-1498-2021
• Recall Event ID: 87578
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: INFINITY_TRAY Custom Procedural Kit - Canada.; containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction.; ; The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling.
• Code Information: Serial Numbers: 001, 005
• Recalling Firm/ Manufacturer: ConMed Corporation; 525 French Rd; Utica NY 13502-5945
• For Additional Information Contact: SAME; 315-862-3533
• Manufacturer Reason for Recall: Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
• FDA Determined Cause: Process control
• Action: Conmed issued international notices Urgent Field Notice via UPS Priority on March 26, 202. Letter states reason for recall, health risk and action to take: Step 1: 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. Please forward a copy of this notice to all facilities which may have affected products in their inventory. It is imperative that all end users of these devices receive this notice and respond immediately. 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) Please process a commercial invoice for the return to the United States referencing your purchase price as a value for Customs purposes and note on the commercial invoice that the return is for evaluation purposes only. Please include the following information on the invoice, with the returned product: CONMED FDA Reg. # 1317214 MDL#: D221270 510K #: Exempt Step 2c: If you DO NOT HAVE any affected devices to return, please complete the business re
• Quantity in Commerce: 2 units
• Distribution: International distribution in the countries of Canada, Italy.
• 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.