Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Recalled by ConMed Corporation Due to Tip Guides are potentially misaligned laterally which could...

Date: March 26, 2021
Company: ConMed Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ConMed Corporation directly.

Affected Products

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.

Quantity: 2 units

Why Was This Recalled?

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

Where Was This Sold?

International distribution in the countries of Canada, Italy.

About ConMed Corporation

ConMed Corporation has 69 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report