Device recall
Z-0874-2015: Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594…
FDA device recall · Class II · Ebi, Llc
Key facts
| Recall number (Z-number) | Z-0874-2015 |
|---|---|
| Recall event | 69981 |
| Product | Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. |
| Product code | OVE |
| Recalling firm | Ebi, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2015 |
| 510(k) numbers | K113796 |
| FEI number | 2242816 |
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