PlainRecalls
FDA Devices Moderate Class II Terminated

Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100

Reported: December 30, 2020 Initiated: November 12, 2020 #Z-0651-2021

Product Description

Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100

Reason for Recall

Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system

Details

Recalling Firm
ConMed Corporation
Units Affected
95 total: 20 units US and 75 units OUS
Distribution
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Location
Utica, NY

Frequently Asked Questions

What product was recalled?
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100. Recalled by ConMed Corporation. Units affected: 95 total: 20 units US and 75 units OUS.
Why was this product recalled?
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Which agency issued this recall?
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0651-2021.