Recall Z-3131-2024 ยท ETN Stimulator, Nerve
Technomed Europe
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
| Date | Sep 12, 2024 (initiated Jul 25, 2024) |
| Status | Open, Classified |
| Reason | Product has have presence of brown discoloration or substance on the hinge area of the device |
| Root cause | Process control |
| 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. |
| Quantity | 71 units |
| Distribution | US: FL, CA, TX, IL, NY, PA, MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110422 | SURGICAL STIMULATORS Technomed Europe, May 26, 2011 |