BEUDAMED
    FDA Enforcement Class II Terminated

    Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

    Recall: Z-2285-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2285-2016
    Event ID
    74563
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    June 22, 2016
    Classification Date
    July 25, 2016
    Termination Date
    April 8, 2021
    Address
    63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States

    Description

    Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

    Reason

    US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

    Code Info

    Lot Numbers: ANC1487¿ ANC1665¿ ANC1672¿ ANC1683¿ ANC2002¿ ANC2003¿ ANC2010¿ ANC2011¿

    Distribution

    US Nationwide Distribution

    Quantity

    170 units