FDA Medical Device Recalls (openFDA)
ConMed Corporation: Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
- Recall number
- Z-0650-2021
- Recalling firm
- ConMed Corporation
- Product
- Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
- Status
- Terminated
- Initiated
- 2020-11-12
- Posted
- not on file
- Terminated
- 2024-04-05
- Reason
- Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
- Root 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
- 73 total: 23 units US;50 units OUS
- Distribution
- Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
- Lot, serial or model codes
- Lot Codes: 201926AB 201942AF 201947AF 202007AF 202011 AF 202015AF 202018AF 202024AF
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3001451571
- Firm city
- Utica
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28