BEUDAMED
    FDA Recall Terminated

    Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint

    Recall: Z-3014-2011 · Initiated July 19, 2011

    Recall

    Recall Number
    Z-3014-2011
    Event Number
    59463
    Firm
    Aesculap Inc
    FEI Number
    2916714
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    July 19, 2011
    Posted
    August 12, 2011
    Terminated
    March 19, 2013
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint

    Reason

    Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.

    Action

    AESCULAP Implant Systems sent an "Important Recall Notification" letter dated to all affected customers. The informed customers of a complaint received where fractured CoCR adapter was found and to return any affected product to the firm. The reason for the fracture is currently under investigation. While the firm is trying to determine the root cause of the fracture, they will be offering the Metha non-modular short hip implants to their customers. Customers are asked to return an Inventory Sheet to AESCULAP. For additional information on this recall call (610) 984-9239 or (610) 984-9300.

    Distribution

    Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN.

    Quantity

    149