Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Notas adicionales en la data
Causa
On 15.05.2012 the manufacturer fa. stryker has published a safety information (update of the instructions for use) on the product abgii modular stems and abgii modular necks (safety information of the basg dated 06.06.2012). this was extended on the basis of new information on 06.07.2012 to a product recall. the manufacturer recalls all products abgii modular stems and abgii modular necks from the market. furthermore, the manufacturer recommends further measures for aftercare of affected patients.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Notas adicionales en la data
Causa
In july 2012 the manufacturer stryker orthopedics recalled the modular hip system abgii (abgii modular stems and abgii modular necks) (see safety information of the basg dated 11.07.2012). with the latest product safety information from january 2013, the company stryker communicates updated information on the medical follow-up of affected patients, which were developed in the course of a continuous collaboration with medical professionals.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Notas adicionales en la data
Causa
Reason: possible joint fractures in the spring arm "acrobat swing ('ac swing') with plastic joint".
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Notas adicionales en la data
Causa
The manufacturer stryker orthopedics reminds affected users with a product safety information about a changed patient management for patients with the affected products. according to the manufacturer's safety information, it is also proposed for symptom-free patients to include them in regular and close-machine controls for examinations. in addition, the manufacturer has announced a partnership with broadspire services, inc. for the settlement of claims and the processing of compensation claims for medical costs in connection with the recall of the above-mentioned product.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Notas adicionales en la data
Causa
The manufacturer, heartware inc., in this safety information document, warns you about the urgent need to observe the operating instructions when operating and maintaining heartware heart support systems.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
Notas adicionales en la data
Causa
In july 2012, the manufacturer stryker orthopedics recalled the modular hip system abgii (abgii modular stems and abgii modular necks products) (see basg safety information dated 12.07.2012). with the current product safety information from august 2014, the manufacturer stryker orthopedics informed affected users / surgeons on a published article from the journal of arthroplasty and reminiscent of the previous communication: safety information of the basg 25.03.2013 and safety information of the basg from 13.02.2013.