Pleasanton, CA, United States
Neotract Inc recalls
2 recalls recorded since 2018, most recently on 24 June 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 June 2022
- Reason
- There is the potential that during implant deployment, the device may not properly deliver a implant.
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1502-2022
- UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Terminated Class II Medical devices
- Recall started
- 6 July 2018
- Terminated
- 2 December 2020
- Reason
- Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.
- Distribution
- US: AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0598-2019
- UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.