Device recall
Z-1806-2013: ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for…
FDA device recall · Class II · Aesculap, Inc.
Key facts
| Recall number (Z-number) | Z-1806-2013 |
|---|---|
| Recall event | 65703 |
| Product | ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for… |
| Product code | MAX |
| Recalling firm | Aesculap, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2014 |
| 510(k) numbers | K071983 |
| FEI number | 2916714 |
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