medical Class II Updated 2020-08-05

Synthes, Inc. recalls MatrixNEURO Screws - Product Usage: The intended use for thi

Recalled Product

MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.


Hazard / Issue

One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.

Issued by

FDA

Distribution: International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
Lot/Code Info: Lot # 30P6198
View official government recall

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