BEUDAMED
    FDA Recall Terminated

    Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts

    Recall: Z-0415-2012 · Initiated August 8, 2011

    Recall

    Recall Number
    Z-0415-2012
    Event Number
    60263
    Firm
    Osteotech Inc
    FEI Number
    3002600221
    Product Code
    MBP
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 8, 2011
    Posted
    January 11, 2012
    Terminated
    December 8, 2011
    Address
    51 James Way, Eatontown, NJ, 07724-2272

    Description

    Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts

    Reason

    Aseptic conditions during the production of these products may have been compromised.

    Action

    Osteotech sent a recall letter dated August 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all units of the affected product. Customers were asked to contact Osteotech Customer Service at 732-578-6699 within two business days of receiving the letter to acknowledge receipt of the letter and to arrange for a return and exchange or credit for the product. For questions regarding this recall call 732-542-2800.

    Distribution

    Worldwide Distribution

    Quantity

    15 units