Stryker recalls C2 Nerve Monitor models due to possible use errors causing nerve injury during surgery. Affected units include specific serial numbers and models sold for intra-operative nerve monitoring.
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.
Stryker is recalling its C2 Nerve Monitor system because its design might lead to use errors that could cause nerve injury during surgery. This affects specific models and serial numbers sold for intra-operative nerve monitoring.
The device's design and instructions may not handle usability issues well, which could lead to use errors. These errors might cause or contribute to nerve injury during surgery.
Surgical teams using the C2 Nerve Monitor for intra-operative nerve monitoring are affected. The risk is highest for those using the device during surgery where precise nerve monitoring is critical.
Check for the model number 8 Channel, 5140-508-280, and the unique device identifier (UDI) 07613327277319. All units with this specific serial number range are affected.
Identify the model number and unique device identifier (UDI) to confirm if your device is affected.
The recall indicates a potential risk of nerve injury during surgery due to possible use errors, but the hazard is not described as causing serious injury in normal use.
The recall does not specify a remedy, so no action is required beyond checking if your device matches the affected model and serial number.
Check for the model number 8 Channel, 5140-508-280, and the unique device identifier (UDI) 07613327277319. All units with this specific serial number are affected.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0024-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0024-2020 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
