The Recall Desk
HighFDA (Devices)·Z-0024-2020·Announced 2019-10-09

Stryker C2 Nerve Monitor Recalled for Potential Nerve Injury Risk

Stryker is recalling 135 C2 Nerve Monitor units because design and instruction issues may lead to use errors that cause nerve injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a design flaw poses a risk of harm (nerve injury), but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 135 units of the C2 Nerve Monitor, 8 Channel (model 5140-508-280, UDI 07613327277319). The device is intended for intra-operative monitoring and stimulation to localize and identify cranial and peripheral motor and mixed motor sensory nerves during surgery.

The recall was initiated because the device's design and instructions may not optimally address usability issues related to its functionality. These issues may result in use errors that potentially cause or contribute to nerve injury. All serial numbers are affected, and the units were distributed nationwide in the United States.

Healthcare providers and facilities should stop using the affected devices and contact Stryker for instructions on how to proceed. The source text does not specify a particular action such as return or repair, nor does it report any specific injuries or illnesses to date.

The recalled product

Product
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 surger
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Monitoring
Hazard
Affected units
135

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Serial Numbers are affected

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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Same hazard · nerve injury

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