Drug recall
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17…
FDA recall event 75882 · Class II · Interventional Spine Inc
Key facts
| Event ID | 75882 |
|---|---|
| Recall numbers | Z-0941-2017 |
| Recalling firm | Interventional Spine Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding. |
| Initiation date | Nov 22, 2016 |
| Report date | Jan 11, 2017 |
| Termination date | Feb 7, 2017 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3003523239 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: