BEUDAMED
    FDA Enforcement Class II Terminated

    TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor

    Recall: Z-2239-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2239-2013
    Event ID
    66037
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2013
    Initiation Date
    August 6, 2013
    Classification Date
    September 17, 2013
    Termination Date
    April 20, 2016
    Address
    150 Minuteman Drive, N/A, Andover, MA, 01810-1031, United States

    Description

    TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor

    Reason

    Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

    Code Info

    50373722 50397580 50397597 50397602 50397606 50414780 50418109 50431745 50431893 50432157 50438518 50438520 50447115 50447117 50447120 50448228 50449526 50449671 50450004 50454012 50454109 50456362 50459638 50460185 50462233 50468656 50469160 50469533

    Distribution

    Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.

    Quantity

    2038 US