BEUDAMED
    FDA Recall Terminated

    Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures.

    Recall: Z-1311-2010 · Initiated February 9, 2010

    Recall

    Recall Number
    Z-1311-2010
    Event Number
    54809
    Firm
    Pelton & Crane Company
    FEI Number
    1017522
    Product Code
    KLC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2010
    Posted
    April 9, 2010
    Terminated
    August 11, 2010
    Address
    11727 Fruehauf Dr, Charlotte, NC, 28273

    Description

    Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures.

    Reason

    The Dental Chair lacks a valid Device History Record.

    Action

    An "URGENT MEDICAL DEVICE RECALL" letter dated February 9, 2010, was delivered in person to the customer. The letter describe the product, problem and action to be taken by the customer. The customer was requested to provide the name and location of the consignee who received the chair so that Pelton & Crane can contact the end user to arrange to replace the affected chair with a new dental chair, and to complete the enclosed Recall Acknowledgement/Return Form and fax to (704) 587-7204. A monthly status report will be submitted to FDA. Please contact Pelton & Crane Customer Care at 1-800-659-6560 or call Mr. Frank Ray directly at 704-587-7227 to let us know where the device is currently stored.

    Distribution

    Nationwide distribution: NC

    Quantity

    1 unit