Recall Z-2277-2020
Genicon, Inc. · initiated August 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Codes / lots: Lots I7931-A and I8069-A
Reason for recall
There is potential for the plastic optical tip to become detached from the metal shaft.
FDA-determined 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.
Details
- Recall number
- Z-2277-2020
- Initiated
- August 21, 2018
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Quantity
- 17 boxes (5 units per box)
- 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
- Recalling firm
- Genicon, Inc., Winter Park, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2266-2020 Class II | Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2267-2020 Class II | Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2268-2020 Class II | Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2269-2020 Class II | Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2270-2020 Class II | Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2271-2020 Class II | Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2272-2020 Class II | Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2273-2020 Class II | Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2274-2020 Class II | Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2275-2020 Class II | Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2276-2020 Class II | Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2278-2020 Class II | Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2279-2020 Class II | Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |