Reported Aug 5, 2020 · Terminated

MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial…

Synthes Produktions GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synthes Produktions GmbH · Eimattstrasse 3 · Oberdorf Bl, N/A · N/A

Is this the product you have?

  • MatrixMIDFACE Screws - Product UsageThe 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
Lot codes and dates
  • Lot # 41P2340
Amount recalled
41 units

Why it was 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).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 15, 2022 · Data as of Sep 19, 4:51 PM UTC

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