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
    35765
  • Event Risk Class
    Class 2
  • Event Number
    Z-1226-06
  • 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=46829
  • 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
    The sterility seal of the package trays may have incomplete seals compromising the sterility of the device.
  • Action
    Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products. Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06.

Device

Device Recall Smith & Nephew
  • Model / Serial
    Lot Numbers: All lot numbers lower than 50156094 Expanded recall:  Lot Numbers: 50172222, 50174786, 50174787, 50175045
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.
  • Product Description
    TriVex 100SV Resector Kit, 4.5 || Part Number: 7205876
  • 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