Drug recall
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is…
FDA recall event 83490 · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Event ID | 83490 |
|---|---|
| Recall numbers | Z-0023-2020, Z-0024-2020 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Product type | Devices |
| Products | C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification…, C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or… |
| Initiation date | Jul 31, 2019 |
| Report date | Oct 9, 2019 |
| Termination date | Mar 24, 2021 |
| City | Portage |
| State | MI |
| Country | United States |
| FEI number | 1811755 |
At a glance
- 1–9 Products in this recall
- 10–99 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: