Neotract recalls
Neotract appears in 2 official U.S. recall notices indexed by RecallRadar, most recently on 2022-08-10.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 2 |
|---|---|
| Published | 2018-12-19 to 2022-08-10 |
| By agency | FDA Device (2) |
| By classification | Class II (2) |
| By status | ongoing (1), terminated (1) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
Recalls
- UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
FDA Device · Class II · 2022-08-10 · Neotract
Reason: There is the potential that during implant deployment, the device may not properly deliver a implant. - UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotra…
FDA Device · Class II · 2018-12-19 · Neotract
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 ca…