BEUDAMED
    FDA Enforcement Class II Terminated

    PANTERA Proximal Humerus Fracture Plate System

    Recall: Z-0599-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0599-2020
    Event ID
    83963
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toby Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 11, 2019
    Initiation Date
    June 5, 2013
    Classification Date
    December 4, 2019
    Termination Date
    September 16, 2020
    Address
    6355 Sw 8th St Ofc 101, West Miami, FL, 33144-4860, United States

    Description

    PANTERA Proximal Humerus Fracture Plate System

    Reason

    Potential suture clip breaking during a humerus fixation surgery.

    Code Info

    1. All implanted plates in the US from 11/26/10 to 06/05/2013 with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE; 2. All implanted plates in Spain and Italy from 11/26/10 to 03/26/2014, with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE; 3. All implanted plates in Panama from 11/26/10 to 05/27/2014, with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE 4. All implanted plates in Puerto Rico, Chile and Argentina from 11/26/10 to 04/11/2014, with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE; 5. All implanted plates in Australia from 11/26/10 to 09/09/2015, with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE

    Distribution

    Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK

    Quantity

    1700 devices