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.
Reported: August 5, 2020 Initiated: June 16, 2020 #Z-2739-2020
Product Description
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.
Reason for Recall
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).
Details
- Recalling Firm
- Synthes Produktions GmbH
- Units Affected
- 41 units
- Distribution
- International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
- Location
- Oberdorf Bl, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Synthes Produktions GmbH. Units affected: 41 units.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2739-2020.
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