BEUDAMED
    FDA Enforcement Class II Terminated

    Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

    Recall: Z-2786-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2786-2020
    Event ID
    86023
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flower Orthopedics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 19, 2020
    Initiation Date
    July 8, 2020
    Classification Date
    August 12, 2020
    Termination Date
    October 8, 2020
    Address
    100 Witmer Rd Ste 280, N/A, Horsham, PA, 19044-2647, United States

    Description

    Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

    Reason

    The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

    Code Info

    Lot Number 1909660035; UDI 00840118115681

    Distribution

    US Nationwide distribution including in the states of AZ, FL, and OH.

    Quantity

    25