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ConMed Corporation recalls Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction.
Recalled December 30, 2020 · FDA recall Z-0650-2021 · ConMed
Hazard
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system · FDA Class II
Units
73 total: 23 units US;50 units OUS
Sold at
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Description
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Product
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Manufacturer(s)
ConMed Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →