BEUDAMED
    FDA Recall Terminated

    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract

    Recall: Z-0598-2019 · Initiated July 6, 2018

    Recall

    Recall Number
    Z-0598-2019
    Event Number
    81576
    Firm
    Neotract Inc
    FEI Number
    3005791775
    Product Code
    PEW
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    July 6, 2018
    Terminated
    December 2, 2020
    Address
    4473 Willow Rd, Ste 100, Pleasanton, CA, 94588-8570

    Description

    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: 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 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.

    Action

    On July 6, 2018, the firm sent an Urgent Medical Device Recall Notification to customers via Federal Express next day Service informing them that 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 existing known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle. It is important to note that this issue impacts only the delivery device. The implant is not impacted. Any implants that have been delivered with the device are not affected. The notification also provides instructions and the following actions to take: 1) If you HAVE affected stock: a. Immediately discontinue use and quarantine any products with the lot numbers listed above, so that the affected products can be returned to the firm. b. Please return the product as follows: i. Complete the enclosed Recall Acknowledgement Form and email to [email protected] or fax it to (925) 401-0699, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will issue you a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to the firm. ii. Write the RGA Number on each box and follow the shipping instructions provided by the firm's Customer Service. 2) If you HAVE NO affected stock: a. Please complete the enclosed Recall Acknowledgement Form and email to [email protected] or fax it to (925) 401-0699, Attn: Customer Service. b. This will allow us to document your receipt of this letter. If customers have any other questions, they can contact their local Urology Consu

    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,

    Quantity

    8,804