Recall Z-2698-2020 ยท JEY Plate, Bone
Synthes, Inc.
MatrixNEURO 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 18, 2020 |
| Status | Terminated |
| Reason | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw. |
| Root cause | Under Investigation by firm |
| Action | DePuy Synthes issued urgent field safety notice in June 2020 to notify customers. The affiliates in the impacted countries will notify affected customers. |
| Quantity | 104 units |
| Distribution | International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042365 | SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM Synthes (Usa), Nov 18, 2004 |