Events

Recall Or Safety Alert for 3.5mm short insertion connector of the Phoenix tibial nail, reference 14-441045. Instrument kits containing the insertion connector: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, 14-444000S

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by N/A.

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
Recall / Safety Alert
Date
2018-05-28
Event Country
Spain
Event Source
AEMPSVFOI
Event Source URL
N/A
Notes / Alerts

The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 recall data from the U.S. and Spain.
Extra notes in the data
Action
Withdrawal from the market of the 3.5 mm short insertion connector of the Phoenix tibial nail manufactured before the design change carried out in March 2017, distributed as a single device or through instrumental kits between February 2008 and November 2017, due to the possibility that the inserters fracture and stay inside the end cap.

Device

3.5mm short insertion connector of the Phoenix tibial nail, reference 14-441045. Instrument kits ...

Model / Serial
Manufacturer
N/A

Manufacturer

N/A

Source
AEMPSVFOI

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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.

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