BEUDAMED
    FDA Enforcement Class II Terminated

    Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.

    Recall: Z-2284-2013 · Reported October 2, 2013

    Enforcement

    Recall Number
    Z-2284-2013
    Event ID
    66355
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Xomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 2, 2013
    Initiation Date
    August 23, 2013
    Classification Date
    September 26, 2013
    Termination Date
    November 7, 2013
    Address
    6743 Southpoint Dr N, N/A, Jacksonville, FL, 32216-6218, United States

    Description

    Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.

    Reason

    One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.

    Code Info

    REF: 1150000 Lot: 0207029284

    Distribution

    Nationwide Distribution (US), including the states of CA, NE, GA, and IL.

    Quantity

    60