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..

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
    71257
  • Event Risk Class
    Class 2
  • Event Number
    Z-1822-2015
  • Event Initiated Date
    2015-04-30
  • Event Date Posted
    2015-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137084
  • 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
    Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
  • Reason
    Sterility of device maybe compromised.
  • Action
    Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number

Device

Smith & Nephew
  • Model / Serial
    All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.
  • Product Description
    ULTRA-FAST FIX Knot Pusher Suture Cutters || Product Number: 72201537 || Intended for Meniscal Repair.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 150 Minuteman Rd, Andover MA 01810-1031
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA