BEUDAMED
    FDA Enforcement Class II Terminated

    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.

    Recall: Z-0155-2016 · Reported October 28, 2015

    Enforcement

    Recall Number
    Z-0155-2016
    Event ID
    72205
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc., Endoscopy Div.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 28, 2015
    Initiation Date
    September 10, 2015
    Classification Date
    October 22, 2015
    Termination Date
    June 23, 2021
    Address
    130 Forbes Blvd, N/A, Mansfield, MA, 02048, United States

    Description

    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.

    Reason

    Sterility of device is compromised due to breach in the packaging

    Code Info

    Lot Numbers: 50045108 50216535 50337080 50381998 50444238 50069259 50225422 50337457 50387855 50451052 50078520 50237917 50340700 50401825 50451745 50105330 50239234 50340703 50408124 50452070 50108397 50244752 50349035 50413603 50455381 50113533 50247214 50350233 50416389 50456956 50118206 50250359 50354625 50425909 50128288 50258565 50356930 50427082 50200340 50271899 50372415 50436696 50207484 50333910 50378455 50437933

    Distribution

    Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela

    Quantity

    603 units