Synthes, Inc. recalls MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleto…

Recall date

June 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2698-2020

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.