BEUDAMED
    FDA Enforcement Class II Terminated

    8.0cm Medium Attachment Product Usage: Pneumatic system

    Recall: Z-2012-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-2012-2017
    Event ID
    76059
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    October 6, 2016
    Classification Date
    May 4, 2017
    Termination Date
    July 26, 2019
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    8.0cm Medium Attachment Product Usage: Pneumatic system

    Reason

    Supplied Directions for Use (DFU) did not contain a recommended service interval.

    Code Info

    All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM.

    Distribution

    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

    Quantity

    1802