Device recall
Z-1491-2019: Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015)…
FDA device recall · Class II · K2M, Inc
Key facts
| Recall number (Z-number) | Z-1491-2019 |
|---|---|
| Recall event | 82716 |
| Product | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to… |
| Product code | KNW |
| Recalling firm | K2M, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2020 |
| 510(k) numbers | K152872 |
| FEI number | 3008599177 |
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