Events

Recall of Smith & Nephew

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc., Endoscopy Div..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72205
  • Event Risk Class
    Class 2
  • Event Number
    Z-0156-2016
  • Event Initiated Date
    2015-09-10
  • Event Date Posted
    2015-10-22
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140173
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • 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.

Device

Smith & Nephew
  • Model / Serial
    50051865 50218987 50317627 50353758 50405160 50451743 50481584 50067670 50230666 50322491 50361146 50408123 50452778 S603582 50081261 50234894 50329870 50372414 50411652 50455378 50120770 50238931 50331389 50376694 50415117 50456676 50121527 50242557 50335918 50379781 50418789 50458024 50180302 50248824 50337463 50381854 50419542 50460414 50194727 50253762 50340709 50383822 50419729 50462250 50204111 50257419 50340713 50387833 50427066 50465245 50207090 50277081 50345713 50390055 50428661 50476968 50209127 50285673 50348084 50395389 50448620 50481431
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • Product 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.
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.

Manufacturer

Smith & Nephew, Inc., Endoscopy Div.
  • Manufacturer Address
    Smith & Nephew, Inc., Endoscopy Div., 130 Forbes Blvd, Mansfield MA 02048
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA