Device recall
Z-0778-2014: Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10…
FDA device recall · Class II · SpineFrontier, Inc.
Key facts
| Recall number (Z-number) | Z-0778-2014 |
|---|---|
| Recall event | 66298 |
| Product | Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height… |
| Product code | HTE |
| Recalling firm | SpineFrontier, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2016 |
| FEI number | 3005977257 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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