This product is a single use sterile device that is used to direct the lesion to the targeted sit...
FDA Recall #Z-2261-2024 — Class II — June 3, 2024
Product Description
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
Reason for Recall
Expired Products distributed to customers
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8 units
Distribution
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Code Information
GTIN: 07613327118438 Lot Number: 1000388946
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated