Device recall
Z-1247-2014: 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is…
FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1247-2014 |
|---|---|
| Recall event | 67775 |
| Product | 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of… |
| Product code | ERL |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2014 |
| 510(k) numbers | K011381 |
| FEI number | 1811755 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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