Recall Z-2261-2024— Stryker Corporation

Name: FDA recall Z-2261-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-03

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2024-06-03. It names one FDA 510(k) clearance: K032406. Product: 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: Expired Products distributed to customers.

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-06-03
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K032406 — STRYKER RF ELECTRODES AND CANNULAEStryker Instruments·cleared 2004-04-01

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

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

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