Recall Z-1502-2022— Neotract Inc
Class II · Ongoing
Class II FDA medical device recall by Neotract Inc, initiated 2022-06-24. It names one FDA 510(k) clearance: K193269. Product: UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool. Reason: There is the potential that during implant deployment, the device may not properly deliver a implant..
- Recalling firm
- Neotract Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-24
- Firm location
- Pleasanton, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Reason for recall
There is the potential that during implant deployment, the device may not properly deliver a implant.
Data sourced from openFDA. This site is unofficial and independent of the FDA.