BEUDAMED
    FDA Recall Terminated

    Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.

    Recall: Z-1081-2010 · Initiated January 13, 2010

    Recall

    Recall Number
    Z-1081-2010
    Event Number
    54253
    Firm
    Integra LifeSciences Corp
    FEI Number
    1121308
    Product Code
    GXQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 13, 2010
    Posted
    March 11, 2010
    Terminated
    March 18, 2010
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339

    Description

    Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.

    Reason

    One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain time points for Suture Retention Strength and Shrink Temperature specifications.

    Action

    An "URGENT PRODUCT RECALL NOTIFICATION" dated January 13, 2010, was sent via Federal Express to customers. The notification described the product, problem, hazard involved and action to be taken by customers. In the event that the customers have in their possession any products from the specific lot number 1091576, the customers are being ask to please immediately quarantine all stock on hand and contact their local Integra Sales representative for further assistance and for arrangements of product return. The customers are being ask to return the enclosed "Recall Acknowledge and Return Form" indicating whether or not they possess any of the affected product identified. Integra will replace any product affected by this Recall that is returned. Please feel free to contact me at 609-936-5407 should you have any additional questions.

    Distribution

    Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.

    Quantity

    94