Device recall
Z-1298-2013: OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an…
FDA device recall · Class II · Integra LifeSciences Corporation
Key facts
| Recall number (Z-number) | Z-1298-2013 |
|---|---|
| Recall event | 64778 |
| Product | OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. |
| Product code | LYC |
| Recalling firm | Integra LifeSciences Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2015 |
| 510(k) numbers | K924408 |
| FEI number | 1121308 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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