ConMed Corporation: KIT_INFINITY_BASE Custom Procedural Kit - Italy, 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.

Recall number

Z-1499-2021

Recalling firm

ConMed Corporation

Product

KIT_INFINITY_BASE Custom Procedural Kit - Italy, 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.

Status

Terminated

Initiated

2021-03-26

Posted

not on file

Terminated

2024-04-05

Reason

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

Root 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

3 units

Distribution

International distribution in the countries of Canada, Italy.

Lot, serial or model codes

Serial Numbers: 1, 2, 3

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

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

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