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Open, Classified

NEUROSIGN Disposable Stimulating Dissector, REF 5888-00

FDA Recall Z-3131-2024 · Posted 2024-09-12

Recalling FirmTechnomed Europe
Recall StatusOpen, Classified
Product CodeETN
Date Initiated2024-07-25
Product Quantity71 units

Reason for Recall

Product has have presence of brown discoloration or substance on the hinge area of the device

Firm 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.

Root Cause

Process control

Distribution Pattern

US: FL, CA, TX, IL, NY, PA, MA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110422SURGICAL STIMULATORSTechnomed Europe · 2011-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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