FDAFDA · Food and drugs·Recall number Z-2739-2020
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.
Published August 5, 2020 · Recall initiated: June 16, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes Produktions GmbH
- Distributor
- International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
- Lot
- Lot # 41P2340
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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