Device recall
Z-1666-2013: InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage…
FDA device recall · Class II · SpineFrontier, Inc.
Key facts
| Recall number (Z-number) | Z-1666-2013 |
|---|---|
| Recall event | 65442 |
| Product | InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan… |
| Product code | HXX |
| Recalling firm | SpineFrontier, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2016 |
| FEI number | 3005977257 |
At a glance
- None 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