Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MatrixNEURO Screws - Product Usage: The intended use for this Recalled by Synthes, Inc. Due to One lot of MatrixNEURO 5mm screws was packaged...

Date: June 18, 2020
Company: Synthes, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Synthes, Inc. directly.

Affected Products

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.

Quantity: 104 units

Why Was This 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.

Where Was This Sold?

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

About Synthes, Inc.

Synthes, Inc. has 43 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report