Recall Z-2266-2020 ยท GEA Cannula, Surgical, General & Plastic Surgery
Genicon, Inc.
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.
| Date | Aug 21, 2018 |
| Status | Open, Classified |
| Reason | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 378 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982472 | GENICON TROCAR Genicon, LC, Feb 4, 1999 |