FDA Recall
Open, Classified
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Recall: Z-3131-2024
·
Initiated July 25, 2024
Recall
- Recall Number
- Z-3131-2024
- Event Number
- 95188
- Firm
- Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands
- FEI Number
- 3001450493
- Product Code
- ETN
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- July 25, 2024
- Posted
- September 12, 2024
Description
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Reason
Product has have presence of brown discoloration or substance on the hinge area of the device
Action
Technomed Europe issued a FIELD SAFETY NOTICE to its consignees on 07/25/2024 via email. The notice explained the issue, potential risk, and requested the cessation of distribution and quarantine of the affected product pending return of the affected product. Distributors were directed to notify those to whom the product was distributed by forwarding a copy of the notice.
Distribution
US: FL, CA, TX, IL, NY, PA, MA
Quantity
71 units