FDA-Device2020-12-30Class II

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

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
95 total: 20 units US and 75 units OUS
Manufactured in
525 French Rd, N/A, Utica, NY, United States
Products
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0651-2021

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