BEUDAMED
    FDA Enforcement Class II Terminated

    TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.

    Recall: Z-1214-2019 · Reported May 1, 2019

    Enforcement

    Recall Number
    Z-1214-2019
    Event ID
    82209
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TriMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 1, 2019
    Initiation Date
    August 24, 2018
    Classification Date
    April 23, 2019
    Termination Date
    December 28, 2020
    Address
    27533 Avenue Hopkins, N/A, Santa Clarita, CA, 91355-3910, United States

    Description

    TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.

    Reason

    The bone screw is shorter than the intended design specification.

    Code Info

    Lot #170281, UDI (01)00842188107108(11)170406(10)170281

    Distribution

    US Distribution to states of FL and MO.

    Quantity

    13 screws