Device recall
Z-1030-2013: Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for…
FDA device recall · Class II · Integra Burlington MA, Inc.
Key facts
| Recall number (Z-number) | Z-1030-2013 |
|---|---|
| Recall event | 64665 |
| Product | Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures. |
| Product code | GYC |
| Recalling firm | Integra Burlington MA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 25, 2014 |
| 510(k) numbers | K924226 |
| FEI number | 1000120652 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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