Z-2279-2020 Class II Ongoing
FDA device recall Z-2279-2020 was initiated by Genicon, Inc. on August 21, 2018 and is designated Class II. Reason for recall: There is potential for the plastic optical tip to become detached from the metal shaft. The recall status is ongoing. Affected quantity: 0 (24 boxes with 5 units/box in inventory).
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
- 0 (24 boxes with 5 units/box in inventory)
Product Description
Genicon Natura Model 210-005-052, 5mm diameter, 70mm 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.
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
Lot I9524-A