Events

Safety Alert for Handle, flexible

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by DePuy 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
    2013-04-16
  • Event Date Posted
    2013-04-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130416.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 handle, flexible medical device manufacturer, depuy synthes, has issued a field safety notice concerning the “handle, flexible [no.: 355.220]”. all lot numbers of the old handle (355.280) are affected. the manufacturer is initiating a voluntary recall of all lots of the "handle, flexible, for no. 355.220" (355.280) which is part of the simplified universal nail system (sun) and the universal nail system (uni), due to the potential lack of the ability to thoroughly clean the instrument. it was reported by the evaluation department in monument/usa that while checking the instrument set a discharge from the handle, flexible was noted. additionally, an investigation was unable to validate the ability to adequately clean the instrument. there have been no complaints or adverse events with regards to the issue. the manufacturer advises users to remove the affected product from use and return them to synthes. the handles in the field will be replaced with a newly design handle. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2013.

Device

Handle, flexible
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Handle, flexible
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes