Device recall
Z-1150-2017: 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer…
FDA device recall · Class II · Stryker Leibinger GmbH & Co. KG
Key facts
| Recall number (Z-number) | Z-1150-2017 |
|---|---|
| Recall event | 76146 |
| Product | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants |
| Product code | GCY |
| Recalling firm | Stryker Leibinger GmbH & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2017 |
| 510(k) numbers | K833586 |
| FEI number | 3002821504 |
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