BEUDAMED
    FDA Enforcement Class II Terminated

    Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.

    Recall: Z-2605-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2605-2018
    Event ID
    80091
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Think Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2018
    Initiation Date
    March 30, 2018
    Classification Date
    August 3, 2018
    Termination Date
    January 24, 2020
    Address
    47201 Lakeview Blvd, N/A, Fremont, CA, 94538-6530, United States

    Description

    Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.

    Reason

    There is a potential for the cutter head to detach from the cutter shaft.

    Code Info

    Lot Numbers 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313

    Distribution

    The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.

    Quantity

    951