Device recall
Z-1353-2015: Vitagel; indicated in surgical procedures (other than in neurosurgical and…
FDA device recall · Class II · Orthovita, Inc., dBA Stryker Orthobiologics.
Key facts
| Recall number (Z-number) | Z-1353-2015 |
|---|---|
| Recall event | 70609 |
| Product | Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. |
| Product code | LMH |
| Recalling firm | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2015 |
| PMA numbers | P050044 |
| FEI number | 1000307073 |
At a glance
- None 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