BEUDAMED
    FDA Recall Terminated

    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    Recall: Z-1483-2013 · Initiated May 7, 2013

    Recall

    Recall Number
    Z-1483-2013
    Event Number
    65258
    Firm
    Zimmer Surgical Inc
    FEI Number
    1526350
    Product Code
    GFD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 7, 2013
    Posted
    June 5, 2013
    Terminated
    December 15, 2014
    Address
    200 W Ohio Ave, Dover, OH, 44622-9642

    Description

    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    Reason

    This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.

    Action

    The firm, Zimmer, sent an "URGENT: DEVICE REMOVAL" notice dated May 7, 2013, to all consignees/customers via FED Ex and Distributors via E-mail. Consignees who had devices repaired received telephone calls as well as the mailed Recall Notice. The Notice identified the devices being recalled; possible adverse events and directions to immediately stop use of and remove affected product, and obtain an RGA (Return Goods Authorization) number by calling (800)348-2759 or email information to [email protected] . to return the devices for repair to:Zimmer Surgical, Attn: QA/RA Dept.- Recall, 200 West Ohio Avenue Dover, Ohio 44622 USA; and to complete and return the Response Form-Immediate Response Required via email to [email protected]. If you have further distributed affected product(s), please provide the customer's information on the Business Response Form to Zimmer. If you have any questions regarding this action, please email us at CorporateQuality. [email protected] or call 1-330-364-0989.

    Distribution

    Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.

    Quantity

    84 units