Events

Safety Alert for Holding Clamps for Multi Vector Distractor

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
    2013-04-09
  • Event Date Posted
    2013-04-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130409c.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 holding clamps for multi vector distractor medical device manufacturer, synthes, has initiated a field safety corrective action concerning holding clamps for multi vector distractor. the affected part numbers included 487.938, 487.939, 487.940, 487.941 and 487.942. the manufacturer has received two complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. no patient harm was reported. the manufacturer advises the affected users to quarantine the affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.

Device

Holding Clamps for Multi Vector Distractor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Holding Clamps for Multi Vector Distractor
  • Manufacturer
    Synthes

Manufacturer

Synthes