FDA recall Z-3131-2024
Technomed Europe · Class II · device
Product
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Reason for recall
Product has have presence of brown discoloration or substance on the hinge area of the device
Distribution
US: FL, CA, TX, IL, NY, PA, MA
Key facts
- Status
- Ongoing
- Initiation date
- 2024-07-25
- Report date
- 2024-09-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Maastricht-Airport, Netherlands
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3131-2024