Events

Recall of Device Recall Smith & Nephew Endoscopic Disposable Blades

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
    52042
  • Event Risk Class
    Class 2
  • Event Number
    Z-1561-2009
  • Event Initiated Date
    2009-05-07
  • Event Date Posted
    2009-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81975
  • 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
    Endoscopic Disposable Blades - Product Code NBH
  • Reason
    Product sterility is compromised due to breach in the sterile packaging.
  • Action
    Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.

Device

Device Recall Smith & Nephew Endoscopic Disposable Blades
  • Model / Serial
    Lot #: 20153856.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.
  • Product Description
    Smith & Nephew Endoscopic Disposable Blades: STONECUTTER ACR,4.0,EP-1,DSP || Part #: 7205330. || DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.
  • 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