Device recall
Z-0078-2017: TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated…
FDA device recall · Class II · Biocompatibles U.K., Ltd.
Key facts
| Recall number (Z-number) | Z-0078-2017 |
|---|---|
| Recall event | 75350 |
| Product | TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters. |
| Product code | NAW |
| Recalling firm | Biocompatibles U.K., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2016 |
| FEI number | 3002124543 |
At a glance
- None 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