Device product
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Z-3131-2024
Product summary
- Firm
- Technomed Europe
- Event
- Event 95188
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 71 units
- Official record key
device-enforcement:Z-3131-2024
Official wording
Reason: Product has have presence of brown discoloration or substance on the hinge area of the device
Code information: UDI/DI 08718375869659, Lot Numbers: 061158, 061380
Distribution pattern: US: FL, CA, TX, IL, NY, PA, MA
Derived failure modes
-
Unknown
Product has have presence of brown discoloration or substance on the hinge area of the device