Events

Field Safety Notices about CMF MatrixMIDFACE, MANDIBLE and ORTHOGNATHIC Screws

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by 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
  • Date
    2017-02-21
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Please note that these products were originally recalled in 2013. unfortunately, due to an error, they were re-distributed. we apologize for this inconvenience. synthes is initiating a voluntary recall of the below mentioned lots of the cmf matriledface, mandible and orthognathic due to the possibility that clips on the screws may be incorrectly etched with the wrong length. each screw is packaged in a “clip” that has a laser etch corresponding to the length of the screw. it has been reported that the etch on the clip does not correspond to the length of the screw. there have been instances in which the screw was longer than the specified etch, as well as the screw being shorter than the specified etch. please note: there has not been any adverse event to patient reported with use of these screws, in all cases of complaints received, there was no patient mm it is not likely that the presence of a screw that is packaged in the incorrect clip holder will result in a serious adverse event. there is a remote probability that a medically reversible or transient adverse health event will result due to a screw being packaged in the incorrect clip holder.

Device

CMF MatrixMIDFACE, MANDIBLE and ORTHOGNATHIC Screws

Manufacturer

Synthes GmbH