FDA recall Z-0651-2021

ConMed Corporation · Class II · device

Product

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

Distribution

Nationwide Foreign: Canada, Thailand, Taiwan, South Africa

Key facts

Status
Terminated
Initiation date
2020-11-12
Report date
2020-12-30
Termination date
2024-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Utica, NY, United States

Primary source

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