BEUDAMED
    FDA Recall Terminated

    Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.

    Recall: Z-0986-2012 · Initiated October 7, 2011

    Recall

    Recall Number
    Z-0986-2012
    Event Number
    60938
    Firm
    Integra LifeSciences Corp
    FEI Number
    1121308
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 7, 2011
    Posted
    February 8, 2012
    Terminated
    May 21, 2013
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339

    Description

    Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.

    Reason

    Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.

    Action

    Integra issued an "Urgent: Product Recall Notification" to customers and sales specialists on 10/7/2011. They were advised of the problem and provided instructions on how to handle the affected product.

    Distribution

    Nationwide Distribution - Including the states of CA, OK, MD and VA.

    Quantity

    45 units