Events

Safety Alert for Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy

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

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
    2013-05-08
  • Event Date Posted
    2013-05-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508e.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
    Medical device safety alert: synthes guide wire ø 2.5 mm, with drill tip, length 300 mm, cobalt-chrome alloy medical device manufacturer, synthes, has issued a field safety notice concerning guide wire ø 2.5 mm, with drill tip, length 300 mm, cobalt-chrome alloy with part number 338.002. according to synthes, wrong material (stainless steel) is indicated on the product label. the product is made of cobalt chrome (l605). the mislabelled product, if detected, may result in user dissatisfaction and use of an alternative product with no harm anticipated. there is an unlikely potential that a user may desire to use a stainless steel guide wire because the patient has a known sensitivity to cobalt chrome-alloy. although highly unlikely, if this situation were to occur the patient could experience an adverse tissue reaction. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy
  • Manufacturer
    Synthes

Manufacturer

Synthes