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Synthes, Inc. recalls MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton
Recalled August 5, 2020 · FDA recall Z-2698-2020 · Synthes
Hazard
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. · FDA Class II
Units
104 units
Sold at
International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
Description
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.
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.
Manufacturer(s)
Synthes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →