Events

Safety Alert for Inserter for Titanium Elastic Nails

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
    2015-03-06
  • Event Date Posted
    2015-03-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150306b.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 inserter for titanium elastic nails medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its inserter for titanium elastic nails [part number: 359.219; lot numbers: 3163015, 8878816]. according to the manufacturer, the affected lots of the inserter for titanium elastic nails (ten) may have the potential for breakage during use. the manufacturer is not requiring an immediate return of affected product(s) as the removal of the ten inserter would prevent the performance of emergency surgery. if an inserter for ten breaks during use, there is the potential for surgical delay while an alternate trauma set is located to complete the procedure. in a worst case scenario, if the inserter for ten breaks during use, the breaking pieces may cause damage to surrounding structure and/or injury to user. the manufacturer will recall the affected products in phases. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 march 2015.

Device

Inserter for Titanium Elastic Nails
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Inserter for Titanium Elastic Nails
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH