Device recall
Z-1089-2019: Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010…
FDA device recall · Class II · Integra Limited
Key facts
| Recall number (Z-number) | Z-1089-2019 |
|---|---|
| Recall event | 82361 |
| Product | Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot. |
| Product code | HWC |
| Recalling firm | Integra Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2020 |
| 510(k) numbers | K051611 |
| FEI number | 3001700044 |
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