Class 2 Device Recall NEUROSIGN Technomed Europe

• Date Initiated by Firm: July 25, 2024
• Date Posted: September 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3131-2024
• Recall Event ID: 95188
• 510(K)Number: K110422
• Product Classification: Stimulator, nerve - Product Code ETN
• Product: NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
• Code Information: UDI/DI 08718375869659, Lot Numbers: 061158, 061380
• FEI Number: 3001450493
• Recalling Firm/ Manufacturer: Technomed Europe; Amerikalaan 71; Maastricht-Airport Netherlands
• For Additional Information Contact: Sanne Habets; 31 434 086868
• Manufacturer Reason for Recall: Product has have presence of brown discoloration or substance on the hinge area of the device
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ETN