Device recall
Z-0012-2007: Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
FDA device recall · Class III · Integrated Orbital Implants Inc
Key facts
| Recall number (Z-number) | Z-0012-2007 |
|---|---|
| Recall event | 36298 |
| Product | Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S |
| Product code | HPZ |
| Recalling firm | Integrated Orbital Implants Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 5, 2006 |
| 510(k) numbers | K982562 |
| FEI number | 3009688114 |
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