Events

Recall of Smith & Nephew

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith And 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
    27738
  • Event Risk Class
    Class 2
  • Event Number
    Z-0247-04
  • Event Initiated Date
    2003-10-10
  • Event Date Posted
    2003-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30444
  • 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
    Accessories, Photographic, For Endoscope (Exclude Light Sources) - Product Code FEM
  • Reason
    Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
  • Action
    Smith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product.

Device

Smith & Nephew
  • Model / Serial
    Part Number: 7204823, Camera Coupler, C-Mount, 30mm F.L.  Serial Numbers (SR prefix):  8632 8646 8652 8659 8670 8679 8693 8709 8714 8633 8647 8655 8660 8675 8686 8694 8711 8716 8635 8648 8657 8665 8676 8687 8712 8727 8636 8649 8658 8668 8677 8691 8707 8713 8728  Part Number: 7204823S, Camera Coupler, C-Mount, 30mm F.L. Serial Number SR8705
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to hospitals Foreign: Australia, Africa, Belgium, Canada, China, Dubai, Egypt, Germany, D\Godmanchester, Italy, Japan, Korea, Malaysia, Norway, Portugal, Singapore, South Africa, Thailand, Taiwan.
  • Product Description
    Smith & Nephew Endocoupler C-Mount 30mm Focal Length || Reference: 7204823 and 7204823S (S indicates unit previously serviced)
  • Manufacturer
    Smith And Nephew, Inc. Endoscopy Division

Manufacturer

Smith And Nephew, Inc. Endoscopy Division
  • Manufacturer Address
    Smith And Nephew, Inc. Endoscopy Division, 150 Minuteman Rd, Andover MA 01810-1031
  • Source
    USFDA