Z-3131-2024Class II

NEUROSIGN Disposable Stimulating Dissector, REF 5888-00

Name: Z-3131-2024 NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Creator: Technomed Europe
Published: 2024-07-25
License: https://open.fda.gov/license/

Technomed Europe / initiated 2024-07-25 / Open, Classified / root cause: manufacturing process

FDA source

Technomed Europe began a recall of NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 on 2024-07-25. FDA classified it as Class II and gives the reason as "Product has have presence of brown discoloration or substance on the hinge area of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3131-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-25
Posted: 2024-09-12
Recalling firm: Technomed Europe
Product: NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Product code: ETN Stimulator, Nerve
Reason for recall: Product has have presence of brown discoloration or substance on the hinge area of the device
Root cause tag: manufacturing process
FDA 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 in commerce: 71 units
Distribution: US: FL, CA, TX, IL, NY, PA, MA
Product codes and lots: UDI/DI 08718375869659, Lot Numbers: 061158, 061380

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3131-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3131-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-12

Product code ETN

K110422Class IISurgical StimulatorsTechnomed Europe / cleared 2011-05-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)