Recall Z-0651-2021— ConMed Corporation

Class II · Terminated

Class II FDA medical device recall by ConMed Corporation, initiated 2020-11-12, terminated 2024-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100. Reason: Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system.

Recalling firm
ConMed Corporation
Classification
Class II
Status
Terminated
Initiated
2020-11-12
Terminated
2024-04-05
Firm location
Utica, NY, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.