Device product
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Z-1502-2022
Product summary
- Firm
- Neotract Inc
- Event
- Event 90548
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,722 systems
- Official record key
device-enforcement:Z-1502-2022
Official wording
Reason: There is the potential that during implant deployment, the device may not properly deliver a implant.
Code information: UDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473 New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163
Distribution pattern: US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None
Derived failure modes
-
Unknown
There is the potential that during implant deployment, the device may not properly deliver a implant.