Device recall
Z-0124-2015: Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set…
FDA device recall · Class II · Cook Medical Incorporated
Key facts
| Recall number (Z-number) | Z-0124-2015 |
|---|---|
| Recall event | 69417 |
| Product | Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is… |
| Product code | KNW |
| Recalling firm | Cook Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2016 |
| 510(k) numbers | K060384 |
| FEI number | 3005580113 |
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