BEUDAMED
    FDA Enforcement Class III Terminated

    CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.

    Recall: Z-1568-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1568-2013
    Event ID
    65362
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    June 3, 2013
    Classification Date
    June 21, 2013
    Termination Date
    October 8, 2014
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    Description

    CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.

    Reason

    As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.

    Code Info

    Lot/Serial Number: 111602, 110864, 102815, 091515, 092563, 110863. Product/Catalogue No: CMC-410-10, CMC-410-20, CMC-410-30, CMC-410-40.

    Distribution

    USA Nationwide Distribution

    Quantity

    467 devices