BEUDAMED
    FDA Recall Terminated

    PANTERA Proximal Humerus Fracture Plate System

    Recall: Z-0599-2020 · Initiated June 5, 2013

    Recall

    Recall Number
    Z-0599-2020
    Event Number
    83963
    Firm
    Toby Orthopaedics, Inc.
    FEI Number
    3008747271
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 5, 2013
    Terminated
    September 16, 2020
    Address
    6355 Sw 8th St, Ofc 101, West Miami, FL, 33144-4860

    Description

    PANTERA Proximal Humerus Fracture Plate System

    Reason

    Potential suture clip breaking during a humerus fixation surgery.

    Action

    Beginning on 06/05/2013 the firm notified their direct consignees of the change in the instructions for use (IFU). On 10/11/2019, the firm followed up with the direct accounts (distributors) to reach out to the users to inform them of the change.

    Distribution

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

    Quantity

    1700 devices