Device recall
Z-1253-2016: 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model…
FDA device recall · Class II · Biomet Spine, LLC
Key facts
| Recall number (Z-number) | Z-1253-2016 |
|---|---|
| Recall event | 73402 |
| Product | 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from… |
| Product code | OVD |
| Recalling firm | Biomet Spine, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2016 |
| 510(k) numbers | K081501 |
| FEI number | 3012447612 |
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