BEUDAMED
    FDA Enforcement Class II Terminated

    OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor

    Recall: Z-2226-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2226-2013
    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

    OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor

    Reason

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

    Code Info

    50272335 50272468 50274466 50274792 50275817 50278112 50282209 50283021 50286518 50286657 50286925 50288725 50290551 50291360 50294564 50295956 50296887 50298073 50301797 50307182 50309401 50309926 50310781 50312498 50314440 50319909 50320249 50322931 50323640 50325599 50326068 50329810 50329975 50333958 50335745 50338377 50341064

    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

    4452 US