Recall Z-3131-2024— Technomed Europe

Name: FDA recall Z-3131-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-25

Class II · Ongoing

Class II FDA medical device recall by Technomed Europe, initiated 2024-07-25. It names one FDA 510(k) clearance: K110422. Product: NEUROSIGN Disposable Stimulating Dissector, REF 5888-00. Reason: Product has have presence of brown discoloration or substance on the hinge area of the device.

Recalling firm: Technomed Europe
Classification: Class II
Status: Ongoing
Initiated: 2024-07-25
Firm location: Maastricht-Airport, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K110422 — SURGICAL STIMULATORSTechnomed Europe·cleared 2011-05-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NEUROSIGN Disposable Stimulating Dissector, REF 5888-00

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.