Device recall
Z-2739-2020: MatrixMIDFACE Screws - Product Usage: The intended use for this device is in…
FDA device recall · Class II · Synthes Produktions GmbH
Key facts
| Recall number (Z-number) | Z-2739-2020 |
|---|---|
| Recall event | 85951 |
| Product | 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. |
| Product code | JEY |
| Recalling firm | Synthes Produktions GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2022 |
| 510(k) numbers | K050608 |
| FEI number | 3002807305 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database