BEUDAMED
    FDA Enforcement Class II Terminated

    7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.

    Recall: Z-2490-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2490-2015
    Event ID
    71967
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 9, 2015
    Initiation Date
    August 6, 2015
    Classification Date
    August 31, 2015
    Termination Date
    January 26, 2017
    Address
    6721 Portwest Dr Ste 160, N/A, Houston, TX, 77024-8019, United States

    Description

    7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.

    Reason

    The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws.

    Code Info

    Lots: TSL002595, TSL002596, TSL002597

    Distribution

    US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.

    Quantity

    28 units