Device product
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm 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.
Z-2266-2020
Product summary
- Firm
- Genicon, Inc.
- Event
- Event 85407
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 378 boxes (5 units per box)
- Official record key
device-enforcement:Z-2266-2020
Official wording
Reason: There is potential for the plastic optical tip to become detached from the metal shaft.
Code information: Lots I7920-F, I7951-F, I7957-F, I7985-F, I7850-F, I7902-F, and I8080-F
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
Derived failure modes
-
Unknown
There is potential for the plastic optical tip to become detached from the metal shaft.