Device recall
Z-1002-2022: SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1002-2022 |
|---|---|
| Recall event | 89862 |
| Product | SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum. |
| Product code | OVB |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K181465 |
| FEI number | 3005099803 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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