Z-0598-2019 Class II Terminated
FDA device recall Z-0598-2019 was initiated by Neotract Inc on July 6, 2018 and is designated Class II. Reason for recall: 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. Fa… The recall status is terminated (terminated December 2, 2020). Affected quantity: 8,804.
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2018
- Initiation Date
- July 6, 2018
- Termination Date
- December 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,804
Product Description
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
Reason for Recall
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 Pattern
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,
Code Information
Model: AN00141 (US) and AN00142 (OUS); Catalog No.: UL400-4; Lots: P37940, P37943, P37953, P37956, P37965, P37971, P37985, P37988, P37995, P38001, P38013, P38020, P38124, P38132