BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0153-2018 · Initiated September 19, 2017

    Recall

    Recall Number
    Z-0153-2018
    Event Number
    78111
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    September 19, 2017
    Terminated
    June 21, 2021
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    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.

    Action

    The recalling firm issued a letter dated 9/19/2017 via email to their customers.

    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