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
    58733
  • Event Risk Class
    Class 2
  • Event Number
    Z-2732-2011
  • Event Initiated Date
    2011-05-06
  • Event Date Posted
    2011-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100188
  • 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
    Saw, powered, and accessories - Product Code HAB
  • Reason
    Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.
  • Action
    Smith & Nephew notified customers by an "URGENT - PRODUCT RECALL 1st NOTIFICATION" letter dated May 6, 2011. The letter describes the product, problem, and actions to be taken. The letter asked customers to call 800-343-5717 (option 3) or send an email to endo.andreturn@smith-nephew.com for a Return Authorization (RA) Number to return product, obtain credit or order replacement blades. Customers are to complete the form and return to the address provided being sure to reference the RA number. For any questions regarding this recall customers were instructed to call 508-337-3731.

Device

Device Recall Smith & Nephew
  • Model / Serial
    Lot Number: 50561144
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and countries of: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, Turkey, and United Kingdom.
  • Product Description
    DYONICS POWER Shaver Blades, || 4.5mm Long Full Radius, package of 3 || Catalog Number: 7205341 || Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
  • 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