Class II — Potential Health Hazard

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

MatrixMIDFACE Screws - Product Usage: The intended use for this Recalled by Synthes Produktions GmbH Due to One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp,...

Date: June 16, 2020
Company: Synthes Produktions GmbH
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 Produktions GmbH directly.

Affected Products

MatrixMIDFACE 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: 41 units

Why Was This Recalled?

One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).

Where Was This Sold?

International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.

About Synthes Produktions GmbH

Synthes Produktions GmbH has 1 total recall tracked by RecallDetector.

Related Recalls

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