Genicon, Inc. recalls Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal han…

Recall date

August 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2275-2020

FDA classification

Class II

Brand / firm

Genicon, Inc.

Sold / distributed

US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.