Device recall
Z-0609-2019: Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit…
FDA device recall · Class II · Mazor Robotics Ltd
Key facts
| Recall number (Z-number) | Z-0609-2019 |
|---|---|
| Recall event | 81521 |
| Product | Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever… |
| Product code | HAW |
| Recalling firm | Mazor Robotics Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 3, 2019 |
| 510(k) numbers | K120812 |
| FEI number | 3005075696 |
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