Device recall
Z-1234-2016: BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a…
FDA device recall · Class II · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-1234-2016 |
|---|---|
| Recall event | 73337 |
| Product | BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via… |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 15, 2016 |
| 510(k) numbers | K003201 |
| FEI number | 1000517638 |
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