BEUDAMED
    FDA Recall Terminated

    LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. Device was manufactured from September 1996 to present.

    Recall: Z-0070-04 · Initiated August 13, 2003

    Recall

    Recall Number
    Z-0070-04
    Event Number
    27501
    Firm
    Misonix, Inc
    FEI Number
    2435119
    Product Code
    LFL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 13, 2003
    Posted
    October 30, 2003
    Terminated
    February 7, 2005
    Address
    1938 New Highway, Farmingdale, NY, 11735-1204

    Description

    LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. Device was manufactured from September 1996 to present.

    Reason

    Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.

    Action

    Misonix, Inc. notified the sole direct consignee, Byron Medical Inc., of the "Corrective Action" by letter on 8/13/03. On 9/17/03, Byron Medical Inc. notified the end users by letter, and provided instructions for proper assembly and warning labels to be affixed to the units.

    Distribution

    1 distributor in Tucson, AZ, for further distribution to end users (physicians and medical facilities) nationwide & Puerto Rico, and in the following countries: Canada, Mexico, Australia, Switzerland, Israel, Saudi Arabia, Cyprus, Greece, Turkey, Germany, Dominican Republic, Sweden, Netherlands, China, Taiwan ROC, and S. Korea.

    Quantity

    1119 units (potentially)