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U.S. Department of Health and Human Services

Class 2 Device Recall INFINITY_TRAY Custom Procedural Kit Canada

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  Class 2 Device Recall INFINITY_TRAY Custom Procedural Kit Canada see related information
Date Initiated by Firm March 26, 2021
Create Date April 27, 2021
Recall Status1 Open3, Classified
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 2
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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