BEUDAMED
    FDA Recall Terminated

    Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand controls button.

    Recall: Z-2484-2018 · Initiated May 8, 2018

    Recall

    Recall Number
    Z-2484-2018
    Event Number
    80329
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    NLQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 8, 2018
    Terminated
    July 29, 2019
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

    Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand controls button.

    Reason

    Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used.

    Action

    Firm notified sales reps via email on 5/8/18 and instructed to have the customers complete response forms.

    Distribution

    US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN

    Quantity

    180 units