Events

Safety Alert for Midface Distractor, complete, distraction length 40 mm, Titanium Alloy (TAN)

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

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
    2014-01-22
  • Event Date Posted
    2014-01-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140122a.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 gmbh midface distractor, complete, distraction length 40 mm, titanium alloy (tan) medical device manufacturer, synthes gmbh, has issued a field safety notice concerning midface distractor, complete, distraction length 40 mm, titanium alloy (tan) (part number: 487.982; lot number: prior to 6913910). as the tab of some distractors may be oversized, there is the potential for the anterior footplates not to fit onto the midface distractor assembly (part number 487.982). because recognition of the defined defect may not be detected until the intraoperative patient treatment period, there is the potential that the index surgical goals will not be achieved and a second unanticipated surgical intervention would be required. according to the manufacturer, there have been no adverse events associated with this issue. the manufacturer advises users to quarantine and return all unused affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 22 january 2014.

Device

Midface Distractor, complete, distraction length 40 mm, Titanium Alloy (TAN)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Midface Distractor, complete, distraction length 40 mm, Titanium Alloy (TAN)
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH