BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0651-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0651-2021
    Event ID
    86746
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    November 12, 2020
    Classification Date
    December 21, 2020
    Termination Date
    April 5, 2024
    Address
    525 French Rd, N/A, Utica, NY, 13502-5945, United States

    Description

    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

    Code Info

    Lot Codes: 201941AE 201946AF 202006AF 202010AF 202015AF 202019AF 202023AF

    Distribution

    Nationwide Foreign: Canada, Thailand, Taiwan, South Africa

    Quantity

    95 total: 20 units US and 75 units OUS