FDA recall Z-2279-2020

Genicon, Inc. · Class II · device

Product

Genicon Natura Model 210-005-052, 5mm diameter, 70mm 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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2018-08-21
Report date
2020-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Winter Park, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2279-2020