BEUDAMED
    FDA Recall Terminated

    Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

    Recall: Z-1040-2008 · Initiated December 18, 2006

    Recall

    Recall Number
    Z-1040-2008
    Event Number
    37183
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    ERL
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    December 18, 2006
    Posted
    February 13, 2008
    Terminated
    July 6, 2012
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

    Reason

    Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process.

    Action

    Anspach issued an Urgent Device Correction letter on 11/27/06, to all manual holders advising them of the error and requested that they update the manual with the corrected instructions. A reply receipt confirming notification was included.

    Distribution

    Worldwide Distribution

    Quantity

    7,399 total units