Device recall
Z-0415-2012: Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch…
FDA device recall · Class II · Osteotech Inc
Key facts
| Recall number (Z-number) | Z-0415-2012 |
|---|---|
| Recall event | 60263 |
| Product | Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts |
| Product code | MBP |
| Recalling firm | Osteotech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2011 |
| 510(k) numbers | K051195 |
| FEI number | 3002600221 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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