Events

Recall of Device Recall Smith and Nephew Inc.

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

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
    62617
  • Event Risk Class
    Class 2
  • Event Number
    Z-2145-2012
  • Event Initiated Date
    2012-07-14
  • Event Date Posted
    2012-08-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111171
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
  • Action
    Smith & Nephew sent an Urgent - Product Recall 1st Notification Letter dated July 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to examine inventory, quarantine immediately, complete the form attached indicating the lot numbers and quantities. The letter also instructed customers to contact Smith & Nephew Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. They will provide customers with instructions for returning affected products and receiving a credit. Each OUS affiliate shall be notified via (email or equivalent) of the recall by Smith & Nephew Inc.; the affiliate must then notify each facility affected by the recall. For question concerning this recall call 405-917-8585 or 978-749-1630.

Device

Device Recall Smith and Nephew Inc.
  • Model / Serial
    Lot Numbers: 655844R, 950143R, 950144R, 950145R, 950146R
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.
  • Product Description
    Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade || Full Radius || Part Number: 7205962 || Product Usage: || The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division

Manufacturer

Smith & Nephew, Inc. Endoscopy Division
  • Manufacturer Address
    Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
  • Source
    USFDA