BEUDAMED
    FDA Recall Terminated

    Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.

    Recall: Z-1461-2008 · Initiated March 7, 2008

    Recall

    Recall Number
    Z-1461-2008
    Event Number
    47401
    Firm
    Alcon Research, Ltd
    FEI Number
    1610287
    Product Code
    HNR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 7, 2008
    Posted
    May 14, 2008
    Terminated
    July 18, 2008
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2001

    Description

    Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.

    Reason

    Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.

    Action

    Consignees were notified by an Urgent Medical Device Recall that was sent via fax on 03/07/08. Users were instructed to cease using the affected products and to return a Recall Acknowledgement Form to the recalling firm. The sales representative will pick up the affected product and discuss replacement alternatives. For additional information, contact 1-800-757-9780.

    Distribution

    Nationwide Distribution including states of AL and CA.

    Quantity

    24 units