Device recall
Z-1297-2013: Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable…
FDA device recall · Class II · Integra LifeSciences Corporation
Key facts
| Recall number (Z-number) | Z-1297-2013 |
|---|---|
| Recall event | 64778 |
| Product | Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the… |
| Product code | LPG |
| Recalling firm | Integra LifeSciences Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2015 |
| PMA numbers | P840062 |
| FEI number | 1121308 |
At a glance
- None Linked 510(k)s
- 10–99 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