Recall Z-2228-2021— Medtronic Neuromodulation

Name: FDA recall Z-2228-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-02

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2021-06-02. It names one FDA 510(k) clearance: K001096. Product: Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000. Reason: Excess nylon flash on the clip..

Recalling firm: Medtronic Neuromodulation
Classification: Class II
Status: Ongoing
Initiated: 2021-06-02
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K001096 — BURR HOLE COVER, MODEL XXImage-Guided Neurologics, Inc.·cleared 2000-10-25

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

Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000

Reason for recall

Excess nylon flash on the clip.

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