BEUDAMED
    FDA Recall Terminated

    37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.

    Recall: Z-0155-2012 · Initiated March 31, 2011

    Recall

    Recall Number
    Z-0155-2012
    Event Number
    60114
    Firm
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical
    FEI Number
    2024312
    Product Code
    EBF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 31, 2011
    Posted
    November 3, 2011
    Terminated
    August 9, 2012
    Address
    1717 W. Collins Ave, Orange, CA, 92867

    Description

    37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.

    Reason

    Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.

    Action

    The firm, Pentron Clinical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 31, 2011, with attached Return Form (via USPS 1st class mail) to all their consignees/customers. The letter describes the product, problem and action to be taken. All consignees/customers were instructed to complete the Recall Return Form via fax to: 1-877-677-8844 and to return any affected product in their inventory. Affected products will have expiration dates between April 2011 and April 2015. Consignees/customers with questions can contact Pentron Clinical Customer Service at (800) 551-0283 directly to handle the arrangements of a quick return and replacement.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Armenia, Austria, Australia, Antigua & Barbuda, Barbados, Belarus, Bulgaria, Canada, Czech Republic, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Poland, Romania, Russia, St. Vincent & Grenadine, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, Ukraine, UK, and Vietnam.

    Quantity

    41,744 units