BEUDAMED
    FDA Recall Terminated

    955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas

    Recall: Z-0920-04 · Initiated April 1, 2002

    Recall

    Recall Number
    Z-0920-04
    Event Number
    28488
    Firm
    Spinal Concepts, Inc
    FEI Number
    3000718496
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 1, 2002
    Posted
    July 20, 2004
    Terminated
    May 11, 2004
    Address
    5301 Riata Park Ct, Bldg F, Austin, TX, 78727-3436

    Description

    955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas

    Reason

    The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.

    Action

    The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.

    Distribution

    Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy

    Quantity

    145