BEUDAMED
    FDA Recall Terminated

    Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA

    Recall: Z-2328-2008 · Initiated July 2, 2008

    Recall

    Recall Number
    Z-2328-2008
    Event Number
    48964
    Firm
    Integra LifeSciences Corp
    FEI Number
    1121308
    Product Code
    MDD
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 2, 2008
    Posted
    September 20, 2008
    Terminated
    September 22, 2008
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339

    Description

    Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA

    Reason

    Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.

    Action

    The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008. Contact Integra at 609-799-3297 if you have questions.

    Distribution

    Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.

    Quantity

    10 units