Device recall
Z-2118-2017: 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion…
FDA device recall · Class I · EBI Patient Care, Inc.
Key facts
| Recall number (Z-number) | Z-2118-2017 |
|---|---|
| Recall event | 77089 |
| Product | 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels. |
| Product code | LOE |
| Recalling firm | EBI Patient Care, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 17, 2018 |
| PMA numbers | P850035, P850035S031 |
| FEI number | 3003435252 |
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