BEUDAMED
    FDA Recall Terminated

    Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500

    Recall: Z-1291-2015 · Initiated February 11, 2015

    Recall

    Recall Number
    Z-1291-2015
    Event Number
    70551
    Firm
    Sybron Dental Specialties
    FEI Number
    2024312
    Product Code
    MMP
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 11, 2015
    Posted
    March 18, 2015
    Terminated
    May 21, 2015
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500

    Reason

    Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.

    Action

    The firm sent out letters to customers on 02/11/15. The firm's letter states that they are willing to replace or credit back customers if they have any of the affected product, and instruct them to contact Metrex Research Customer Care at 1-800-841-1428 in order to receive an RMA number. The firm also requests that customer complete and fax back the enclosed reply form in order to confirm receipt of this advisory notification. The firm also states that if the customer is a distributor that they identify the customers that might have received the affected product, and contact them within 48 hours.

    Distribution

    Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,

    Quantity

    172