BEUDAMED
    FDA Recall Terminated

    Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty.

    Recall: Z-2228-2008 · Initiated May 29, 2008

    Recall

    Recall Number
    Z-2228-2008
    Event Number
    48693
    Firm
    OrthoPro LLC
    FEI Number
    3005252592
    Product Code
    KWD
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 29, 2008
    Posted
    September 18, 2008
    Terminated
    September 24, 2008
    Address
    3450 Highland Dr, Ste 303, Salt Lake City, UT, 84106-4369

    Description

    Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty.

    Reason

    Labeling presented conflicting information as to whether device was sterile or not.

    Action

    All sales agents were verbally notified on 05/29/2008 and told to locate and return all available affected implants. For assistance, contact OrthoPro at 1-801-746-0208.

    Distribution

    AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA.

    Quantity

    210 units