BEUDAMED
    FDA Recall Terminated

    EnDura No-React Dural Substitute 12 cm Diameter

    Recall: Z-0832-2007 · Initiated May 4, 2007

    Recall

    Recall Number
    Z-0832-2007
    Event Number
    37903
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 4, 2007
    Posted
    May 24, 2007
    Terminated
    September 24, 2008
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    EnDura No-React Dural Substitute 12 cm Diameter

    Reason

    Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t

    Action

    On May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product.

    Distribution

    Nationwide Distribution to hospitals and medical centers

    Quantity

    12,736 for all recalls Z-0827-0832-2007