Events

Recall of Device Recall 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 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
    35766
  • Event Risk Class
    Class 2
  • Event Number
    Z-1232-06
  • Event Initiated Date
    2006-06-19
  • Event Date Posted
    2006-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46835
  • 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
    Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
  • Action
    Smith & Nephew notified consignees by Certified letter dated 6/19/06. Accounts are requested to return product. Smith & Nephew expanded the recall on 8/2/5/06 by letter to include addtional lot numbers.

Device

Device Recall Smith & Nephew
  • Model / Serial
    Lot Numbers: Equal to or lower 50169658 (or within lot S595485S)  Expanded Recall: Lot Numbers: 50169659, 50172149, 50172152, 50173174, 50174697, 50175101
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul
  • Product Description
    Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible || Product number: 7209855
  • 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