Device recall
Z-0045-2017: ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model…
FDA device recall · Class II · LDR Spine USA, Inc.
Key facts
| Recall number (Z-number) | Z-0045-2017 |
|---|---|
| Recall event | 75068 |
| Product | ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device. |
| Product code | LXH |
| Recalling firm | LDR Spine USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2017 |
| 510(k) numbers | K082262, K090507, K153495 |
| FEI number | 3004903783 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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