NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
FDA device recall Z-3131-2024 · posted 2024-09-12 · Open, Classified
Recall details
- Recalling firm
- Technomed Europe
- Reason for recall
- Product has have presence of brown discoloration or substance on the hinge area of the device
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ETN
- Quantity affected
- 71 units
- Distribution
- US: FL, CA, TX, IL, NY, PA, MA
- Date initiated
- 2024-07-25
- Date posted
- 2024-09-12
- Location
- Maastricht-Airport, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL STIMULATORS (K110422) | Technomed Europe | 2011-05-26 |