Device recall
Z-0086-2013: Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product…
FDA device recall · Class II · Osteotech Inc
Key facts
| Recall number (Z-number) | Z-0086-2013 |
|---|---|
| Recall event | 62569 |
| Product | Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in… |
| Product code | MBP |
| Recalling firm | Osteotech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 17, 2014 |
| 510(k) numbers | K042707, K043048, K051188, K051195 |
| FEI number | 3002600221 |
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