Device recall
Z-2624-2011: Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic…
FDA device recall · Class II · Integrated Orbital Implants Inc
Key facts
| Recall number (Z-number) | Z-2624-2011 |
|---|---|
| Recall event | 58877 |
| Product | Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable… |
| Product code | hpz |
| Recalling firm | Integrated Orbital Implants Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2012 |
| 510(k) numbers | K003338 |
| 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