BEUDAMED
    FDA Recall Terminated

    AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

    Recall: Z-0829-2014 · Initiated March 31, 2011

    Recall

    Recall Number
    Z-0829-2014
    Event Number
    67176
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBC
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    March 31, 2011
    Posted
    January 27, 2014
    Terminated
    July 18, 2019
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

    Reason

    Cutter was longer than was stated on the label

    Action

    Anspach sent an Urgent Medical Device Product Removal letter dated March, 32, 2013, to all affeced customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inventory their batches and return the products for replacement. Customers needing assistance were instructed to contact Anspach at 800-327-6887. For questions regarding this recall, call 800-327-6887.

    Distribution

    Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.

    Quantity

    599 cutting burs