Stryker Recalls C2 Nerve Monitor Due to Usability Design Issues
Stryker is recalling 135 C2 Nerve Monitor units because design and instruction usability issues may lead to use errors and potential nerve injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device where design flaws may lead to use errors causing nerve injury, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 135 units of the C2 Nerve Monitor, 4 Channel (Model 5140-508-240, UDI 07613327177329). 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 covers all serial numbers for this specific model.
The recall was initiated because the device's design and instructions may not optimally address usability issues related to its functionality. These usability issues may result in use errors that potentially cause or contribute to nerve injury. The affected units were distributed nationwide in the United States.
Healthcare facilities and users should stop using the affected C2 Nerve Monitor units and contact Stryker for further instructions on the recall process.
The recalled product
- Product
- 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 of cranial and peripheral motor and mixed motor sensory nerves during…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- 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.
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