BEUDAMED
    FDA Enforcement Class II Terminated

    Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.

    Recall: Z-0153-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0153-2018
    Event ID
    78111
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2017
    Initiation Date
    September 19, 2017
    Classification Date
    November 20, 2017
    Termination Date
    June 21, 2021
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.

    Reason

    There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

    Code Info

    All lot numbers

    Distribution

    Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

    Quantity

    656 devices