BEUDAMED
    FDA Recall Terminated

    Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005

    Recall: Z-0549-03 · Initiated October 31, 2002

    Recall

    Recall Number
    Z-0549-03
    Event Number
    25056
    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 PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005

    Reason

    Brochures approved for international distribution only were 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 inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm 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, SC, VA, MD, PA, MA, CT, VT, ME, ID, LA, WI, NE

    Quantity

    Unknown at this time