Device recall
Z-2901-2018: QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING…
FDA device recall · Class II · Stryker Leibinger GmbH & Co. KG
Key facts
| Recall number (Z-number) | Z-2901-2018 |
|---|---|
| Recall event | 80371 |
| Product | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium |
| Product code | GWO |
| Recalling firm | Stryker Leibinger GmbH & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2019 |
| 510(k) numbers | K120352 |
| FEI number | 3002821504 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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