The Recall Desk

FDA (Devices) recall action 83490

Stryker Instruments Div. of Stryker Corporation recalled 2 products on 2019-10-09

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-10-09
Critical
0
Units
270

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-10-09

    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.

    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 surger
    Category
    Distribution
    0 states