Events

Field Safety Notices about Traumacem Needle Kit (used with PFNA systems)

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Möller Medical GmbH / Synthes GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    442:2011/78693
  • Event Country
    Sweden
  • Event Source
    SMPA
  • Event Source URL
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2013/Engangsprodukter--Traumacem-Needle-Kit-anvands-med-PFNA-system--Moller-Medical-GmbH--Synthes-GmbH/#
  • Notes / Alerts
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 Sweden.
  • Extra notes in the data
    DE-BfArM-2011-10-04-172, 1543/11
  • Action
    Products should be revoked. The products used in orthopedic operations with PFNA systems manufactured by Synthes GmbH. Since PFNA system has been modified not fit the cannula in question further with the system. If the recalled type of needles used the patient may get damage. Synthes GmbH has been responsible for the recall. If necessary, contact is made with Synthes AB.

Device

Traumacem Needle Kit (used with PFNA systems)

Manufacturer

Möller Medical GmbH / Synthes GmbH
  • Source
    SMPA