Device recall
Z-0809-2016: Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-0809-2016 |
|---|---|
| Recall event | 73057 |
| Product | Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1… |
| Product code | OVE |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 1, 2017 |
| 510(k) numbers | K132582 |
| FEI number | 1038671 |
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