Events

Recall of Device Recall Smith& Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector

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
    60375
  • Event Risk Class
    Class 2
  • Event Number
    Z-0463-2012
  • Event Initiated Date
    2011-11-07
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105197
  • 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
    Manufacturing issue: the distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
  • Action
    Smith & Nephew Inc. Endoscopy Division notified facilities on 11/7/11 via an "Urgent - Product Recall 1st Notification - Urgent" letter and/or phone. The letter identified the affected product and the reason for the recall. It also discussed the potential risks, customer actions, and instructions for the return of the product. Customers were to check their inventory and locate any of the affected product. They were to also complete the requested contact information and return the notification letter. In addition, customers were to contact Smith & Nephew Endoscopy Division Returns Group at endo.andreturns@smith-nephew.com for information on how to return the affected product and receive replacement product. Questions, contact Hoangthi Le directly by phone at 508-337-3731.

Device

Device Recall Smith& Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector
  • Model / Serial
    Lot Numbers: 830567, 830568,  830569,  863004,  868509,  868519,  875226,  875227, and 897191.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela.
  • Product Description
    Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector || Catalog Number: 7205962.
  • 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