CMF MatrixMIDFACE, MANDIBLE and ORTHOGNATHIC Screws 에 대한 현장 안전성 서한

Field Safety Notice

2017-02-21

Slovenia

AMPMDRS

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.