BEUDAMED
    FDA Recall Terminated

    Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.

    Recall: Z-1524-2010 · Initiated June 17, 2009

    Recall

    Recall Number
    Z-1524-2010
    Event Number
    55191
    Firm
    Ascension Orthopedics, Inc
    FEI Number
    3002788818
    Product Code
    NEG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 17, 2009
    Posted
    May 4, 2010
    Terminated
    September 27, 2010
    Address
    8700 Cameron Rd, Ste 100, Austin, TX, 78754

    Description

    Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.

    Reason

    Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.

    Action

    Ascension Orthopedics, Inc. issued e-mail notification to distributors and sales representatives beginning June 2009. Consignees were instructed return affected product to the firm for replacement. For further information, contact Ascension Orthopedics, Inc. at 1-512-836-5001 extension 1549.

    Distribution

    Worldwide Distribution - Worldwide Distribution - United States, United Kingdom, France, Australia, Belgium, Czech Republic, Canada, Germany, The Netherlands and South Africa.

    Quantity

    129 units (64 US, 65 OUS)