BEUDAMED
    FDA Enforcement Class II Terminated

    TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor

    Recall: Z-2238-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2238-2013
    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 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor

    Reason

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

    Code Info

    50373723 50389654 50389655 50397577 50397596 50397599 50397605 50417226 50431744 50431853 50433695 50437528 50440608 50441690 50447116 50447118 50447119 50448227 50454009 50454867 50461412 50467503 50469159 50470653

    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

    1571 US