Z-2739-2020 Class II Terminated
FDA device recall Z-2739-2020 was initiated by Synthes Produktions GmbH on June 16, 2020 and is designated Class II. 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 wi… The recall status is terminated (terminated April 15, 2022). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 16, 2020
- Termination Date
- April 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
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).
Distribution Pattern
International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
Code Information
Lot # 41P2340