Device recall
Z-0431-2021: Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile…
FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-0431-2021 |
|---|---|
| Recall event | 86670 |
| Product | Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001 |
| Product code | HBF |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2022 |
| 510(k) numbers | K082010 |
| FEI number | 1811755 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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