Events

Safety Alert for Tendon Stripper, slotted, 5.0 mm I.D. x 12” working length

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Smith & Nephew.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-07-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110711.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: smith & nephew, tendon stripper, slotted, 5.0 mm i.D. x 12” working length it has come to our attention that smith & nephew endoscopy has issued a product recall regarding eleven lots of tendon stripper. according to the local supplier, hong kong is affected. the material of shaft tip (casting) does not meet with the manufacturer’s specification, which could result in rusting of the tendon strippers. this condition could make the device difficult to clean and therefore challenging to adequately sterilize. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Tendon Stripper, slotted, 5.0 mm I.D. x 12” working length
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [11 Jul 2011] Smith & Nephew, Tendon Stripper, slotted, 5.0 mm I.D. x 12” working length.
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew