RecallDepth

Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Company
Genicon, Inc.
Recall Initiated
August 21, 2018
Recall Number
Z-2271-2020
Quantity
12 boxes (5 units per box)
Firm Location
Winter Park, FL

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

Lot / Code Info

Lot I7781-C

Root Cause

Process control

Action Taken

A customer letter will be issued to impacted customers during the week of 5/25/2020. Customers are asked to inspect their inventory for impacted lots and return the devices to Genicon. Customers may contact Mr. Justin Colon, Genicon Customer Service on Mon-Thurs 9am-4pmEST at 407-657-4851, extension #800.

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