Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
This recall is currently active, issued August 21, 2018. It was issued by Genicon, Inc..
- Company
- Genicon, Inc.
- Recall Initiated
- August 21, 2018
- Recall Number
- Z-2269-2020
- Quantity
- 2 boxes (5 units per box)
- Firm Location
- Winter Park, FL
- Official Source
- View on FDA website ↗
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 I9613-A
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.