Recall Z-2739-2020 ยท JEY Plate, Bone
Synthes Produktions GmbH
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.
| Date | Jun 16, 2020 |
| Status | Terminated |
| 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). |
| Root cause | Under Investigation by firm |
| Action | DePuy Synthes issued urgent field safety notice in June 26, 2020 to notify customers. The affiliates in the impacted countries will notify affected customers. |
| Quantity | 41 units |
| Distribution | International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050608 | SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM Synthes (Usa), May 18, 2005 |