BEUDAMED
    FDA Recall Terminated

    ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.

    Recall: Z-2302-2015 · Initiated April 13, 2015

    Recall

    Recall Number
    Z-2302-2015
    Event Number
    71212
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 13, 2015
    Posted
    July 29, 2015
    Terminated
    August 25, 2016
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.

    Reason

    G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

    Action

    Anspach sent an Urgent Notice: Medical Device Recall (Correction) letter of Anspach G1 Dissection Tools dated May 6, 2015, to all affected customers. Customers were not required to return their inventory of GI Dissection tools. Customers were instructed to complete, sign, and return the attached reply form confirming receipt of the letter by fax or email. Customers were also instructed to forward the letter as appropriate immediately. Customers with questions should contact the Complaint Handling Unit Manager at 561-494-3673 or contact their Anspach Sales Representative. For questions regarding this recall call 561-627-1080.

    Distribution

    Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.

    Quantity

    88 tools.