BEUDAMED
    FDA Recall Terminated

    AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 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-2287-2016 · Initiated June 22, 2016

    Recall

    Recall Number
    Z-2287-2016
    Event Number
    74563
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 22, 2016
    Terminated
    April 8, 2021
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    Description

    AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 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.

    Action

    The firm, LeMaitre Vascular, Inc., sent an "URGENT: Medical Device Correction" letter dated June 20, 2016 to its distributors and hospitals via Priority mail. The letter describes the product, problem and actions to be taken. The customers were informed of the intended use of the devices and the correct catalog numbers to order for the dura application. The customers were instructed to return unused devices for an exchange or refund; destroy any Anastoclip related marketing materials that you have received from Lemaitre between October 25- 2015 and June 15, 2016, and complete and return the reply form for reconciliation of this recall via fax at 781-221-2223, email: [email protected] or by mail. LeMaitre Vascular, Inc. will replace any affected device with a new device labeled for dura closure or issue a credit per request. Questions concerning this safety notice, please contact me at 781-221-2266 ext. 183.

    Distribution

    US Nationwide Distribution

    Quantity

    39 units