Z-3131-2024 Class II Ongoing
FDA device recall Z-3131-2024 was initiated by Technomed Europe on July 25, 2024 and is designated Class II. Reason for recall: Product has have presence of brown discoloration or substance on the hinge area of the device The recall status is ongoing. Affected quantity: 71 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- July 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 units
Product Description
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 Pattern
US: FL, CA, TX, IL, NY, PA, MA
Code Information
UDI/DI 08718375869659, Lot Numbers: 061158, 061380