Z-2268-2020 Class II Ongoing

Recalled by Genicon, Inc. — Winter Park, FL

Recall Details

Product Type
Devices
Report Date
June 17, 2020
Initiation Date
August 21, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
42 boxes (5 units per box)

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.

Distribution Pattern

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

Code Information

Lots I7779-C and I8144-C