Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-0024-2020

Z-0024-2020 Class II Terminated

Recalled by Stryker Instruments Div. of Stryker Corporation — Portage, MI

Recall Details

Product Type
Devices
Report Date
October 9, 2019
Initiation Date
July 31, 2019
Termination Date
March 24, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
135

Product Description

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 of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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 contributing to nerve injury.

Distribution Pattern

US Nationwide distribution.

Code Information

All Serial Numbers are affected

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