BEUDAMED
    FDA Recall Terminated

    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.

    Recall: Z-0156-2016 · Initiated September 10, 2015

    Recall

    Recall Number
    Z-0156-2016
    Event Number
    72205
    Firm
    Smith & Nephew, Inc., Endoscopy Div.
    FEI Number
    1219602
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    September 10, 2015
    Posted
    October 22, 2015
    Terminated
    June 23, 2021
    Address
    130 Forbes Blvd, Mansfield, MA, 02048

    Description

    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 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

    Action

    Smith & Nephew issued Recall Notification Letter dated September 10, 2015 via overnight Federal Express. Customers were requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the Inventory Return Certification Form on the following page, indicating the lot numbers and quantities that need to be returned and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. Send the completed form to the Smith & Nephew's Field Action Department via email at FieldActions@smithnephew. com or fax +1-901-566-7975 to obtain a return authorization (RA) number. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment.

    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

    1287 units