Oberdorf Bl, N/A, Switzerland
Synthes Produktions GmbH recalls
1 recall recorded since 2018, most recently on 16 June 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 June 2020
- Terminated
- 15 April 2022
- 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).
- Distribution
- International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.