BEUDAMED
    FDA Recall Terminated

    16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

    Recall: Z-1037-2015 · Initiated December 10, 2014

    Recall

    Recall Number
    Z-1037-2015
    Event Number
    70184
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBC
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    December 10, 2014
    Posted
    February 2, 2015
    Terminated
    May 9, 2016
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

    Reason

    Customer complaint indicating the color bands on the MIA16-G1 were not correct.

    Action

    Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice. If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.

    Distribution

    US Distribution to the states of: NC and CA., and Internationally to Switzerland.

    Quantity

    8