FDA Enforcement
Class II
Terminated
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.
Recall: Z-2739-2020
·
Reported August 5, 2020
Enforcement
- Recall Number
- Z-2739-2020
- Event ID
- 85951
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Synthes Produktions GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 5, 2020
- Initiation Date
- June 16, 2020
- Classification Date
- July 30, 2020
- Termination Date
- April 15, 2022
- Address
- Eimattstrasse 3, N/A, Oberdorf Bl, N/A, N/A, Switzerland
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
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).
Code Info
Lot # 41P2340
Distribution
International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
Quantity
41 units