Recall Z-2268-2020— Genicon, Inc.

Name: FDA recall Z-2268-2020
Creator: U.S. Food and Drug Administration
Published: 2018-08-21

Class II · Ongoing

Class II FDA medical device recall by Genicon, Inc., initiated 2018-08-21. It names one FDA 510(k) clearance: K982472. Product: Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.. Reason: There is potential for the plastic optical tip to become detached from the metal shaft..

Recalling firm: Genicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2018-08-21
Firm location: Winter Park, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K982472 — GENICON TROCARGenicon, LC·cleared 1999-02-04

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 GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

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