Device product
Genicon Natura Model 210-005-152, 5mm diameter, 100mm 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.
Z-2275-2020
Product summary
- Firm
- Genicon, Inc.
- Event
- Event 85407
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 102 boxes (5 units per box)
- Official record key
device-enforcement:Z-2275-2020
Official wording
Reason: There is potential for the plastic optical tip to become detached from the metal shaft.
Code information: Lots I7968-A, I8182-A
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.