Device recall
Z-0941-2017: G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01…
FDA device recall · Class II · Interventional Spine Inc
Key facts
| Recall number (Z-number) | Z-0941-2017 |
|---|---|
| Recall event | 75882 |
| Product | G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with… |
| Product code | MAX |
| Recalling firm | Interventional Spine Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2017 |
| 510(k) numbers | K152156, K160464 |
| FEI number | 3003523239 |
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