FDA-Device2020-12-30Class II
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
ConMed Corporation
Hazard
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
Sold states
Nationwide Foreign: Canada, Thailand, Taiwan, South Africa
Affected count
73 total: 23 units US;50 units OUS
Manufactured in
525 French Rd, N/A, Utica, NY, United States
Products
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2021Don't want to check this manually?
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