Device recall
Z-1761-2025: Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the…
FDA device recall · Class II · Augmedics Ltd.
Key facts
| Recall number (Z-number) | Z-1761-2025 |
|---|---|
| Recall event | 96686 |
| Product | Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. |
| Product code | OLO |
| Recalling firm | Augmedics Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K211188 |
| FEI number | 3016571711 |
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