Recall Z-1076-2018— Genicon, Inc.

Name: FDA recall Z-1076-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-19

Class II · Terminated

Class II FDA medical device recall by Genicon, Inc., initiated 2017-07-19, terminated 2020-05-18. It names one FDA 510(k) clearance: K162059. Product: GENICON EZEE Retrieval, sterile, Rx only.. Reason: Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use..

Recalling firm: Genicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-19
Terminated: 2020-05-18
Firm location: Winter Park, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K162059 — EZEE RETRIEVALGenicon, Inc.·cleared 2016-09-29

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

GENICON EZEE Retrieval, sterile, Rx only.

Reason for recall

Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

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