Device recall
Z-0022-2014: Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest…
FDA device recall · Class II · Harvest Technologies Corporation
Key facts
| Recall number (Z-number) | Z-0022-2014 |
|---|---|
| Recall event | 66268 |
| Product | Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to… |
| Product code | FMF |
| Recalling firm | Harvest Technologies Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2014 |
| 510(k) numbers | K043261 |
| FEI number | 1000117351 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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