BEUDAMED
    FDA Recall Terminated

    ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

    Recall: Z-1887-2014 · Initiated November 28, 2012

    Recall

    Recall Number
    Z-1887-2014
    Event Number
    64247
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 28, 2012
    Posted
    June 25, 2014
    Terminated
    August 7, 2014
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

    Reason

    The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

    Action

    The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.

    Distribution

    Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

    Quantity

    6