BEUDAMED
    FDA Recall Terminated

    Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

    Recall: Z-2785-2020 · Initiated July 8, 2020

    Recall

    Recall Number
    Z-2785-2020
    Event Number
    86023
    Firm
    Flower Orthopedics Corporation
    FEI Number
    3009996260
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 8, 2020
    Posted
    August 12, 2020
    Terminated
    October 8, 2020
    Address
    100 Witmer Rd, Ste 280, Horsham, PA, 19044-2647

    Description

    Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - 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).

    Action

    The Regional Business Director notified the customer by telephone and informed them that there was an issue with the newly released calcaneus plates. The 6 units were requested to be returned to Flower Orthopedics.

    Distribution

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

    Quantity

    25