International Medical Devices Database

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
2015-06-19
Event Date Posted
2015-06-19
Event Country
Hong Kong
Event Source
DH
Event Source URL
https://www.mdco.gov.hk/english/safety/recalls/recalls_20150619a.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 tfna helical-blade impactor medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its tfna helical-blade impactor [part number: 03.037.024; lot number: t102762]. the manufacturer has initiated a voluntary medical device recall of one lot of the tfna helical-blade impactor of the tfn-advancedtm proximal femoral nailing system. the tfna system is intended for treatment of proximal femoral fractures. the height of one of the three guiding pins of the tfna helical-blade impactor may potentially be oversized. if the guiding pin were to be oversized, the tfna helical-blade impactor (part number 03.037.024) would not be able to pass through the guide sleeve (part number 03.037.017). if the tfna helical-blade impactor is not able to pass through the guide sleeve, there is the potential for surgical delay while an alternative trauma set is located to complete the procedure. 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 19 june 2015.

Device

TFNA Helical-Blade Impactor

Model / Serial
Product Description
Medical Device Safety Alert: Synthes GmbH TFNA Helical-Blade Impactor
Manufacturer
Synthes GmbH

Manufacturer

Synthes GmbH

Manufacturer Parent Company (2017)
Johnson & Johnson
Source
DH

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)

Safety Alert for TFNA Helical-Blade Impactor

What is this?

Device

TFNA Helical-Blade Impactor

Manufacturer

Synthes GmbH