BEUDAMED
    FDA Recall Terminated

    Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal

    Recall: Z-0550-03 · Initiated October 31, 2002

    Recall

    Recall Number
    Z-0550-03
    Event Number
    25057
    Firm
    Ascension Orthopedics, Inc
    FEI Number
    3002788818
    Product Code
    ---
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2002
    Posted
    February 8, 2003
    Terminated
    December 3, 2003
    Address
    8200 Cameron Road, Ste C-140, Austin, TX, 78754-3832

    Description

    Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal

    Reason

    Literature approved for international distribution only was distributed domestically.

    Action

    The firm began to contact all US distributors on October 31, 2002, and all US sales representatives on November 1, 2002, by e-mail to initiate an examination of all Ascension MCP professional labeling in their stock, and request return of incorrect labeling. The firm additionally, initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.

    Distribution

    AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, VA, SC, MD, MA, CT, VT, ME, ID, LA, WI, NE

    Quantity

    Currently being determined