Stryker Instruments Div. of Stryker Corporation

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 7

Known Identifiers & Locations

FEI Numbers 1811755
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (7)

Recall # Product Description Initiation Date Status Action
Z-0005-2007 Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000. Reason: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. 2006-09-08 Terminated View Details
Z-0006-2007 Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000. Reason: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. 2006-09-08 Terminated View Details
Z-0007-2007 Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064. Reason: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. 2006-09-08 Terminated View Details
Z-0008-2007 Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000. Reason: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. 2006-09-08 Terminated View Details
Z-0023-2020 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 surgery. Reason: 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. 2019-07-31 Terminated View Details
Z-0024-2020 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: 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. 2019-07-31 Terminated View Details
Z-0034-06 Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000. Reason: The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user. 2005-07-22 Terminated View Details

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