BEUDAMED
    FDA Recall Terminated

    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    Recall: Z-1834-2015 · Initiated June 1, 2015

    Recall

    Recall Number
    Z-1834-2015
    Event Number
    71394
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    NLM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 1, 2015
    Posted
    June 25, 2015
    Terminated
    August 16, 2016
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    Reason

    Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

    Action

    On 06/01/15 a customer notification letter was sent out by the firm. The notification letter instructs customers to stop using the affected lots of the recalled product, and should consider other trocar models reprocesses by Stryker as an alternative. The letter notes that attached is a Effectiveness Check Form and complete list of affected lots shipped to the facility. A Stryker Sustainability Solutions Sales Representative will be sent to check the inventory of the affected lots. Once the inventory is checked the affected lots will be removed. The firm will complete a Recall Effectiveness Check Form . The form is to be completed even if no affected product is found. The firm requests that the form be returned to the sales representative or fax to 480-809-4975. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. The firm states that adverse reactions or quality problems experiences with the use of the product may be reported to the firm's hotline 888-888-3433 x5572, or at www.stryker.com/productexperience as well as through FDA's MedWatch Adverse Event Reporting program.

    Distribution

    Distributed Nationwide including Puerto Rico.

    Quantity

    147,351