BEUDAMED
    FDA Recall Terminated

    PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

    Recall: Z-0383-2018 · Initiated June 15, 2017

    Recall

    Recall Number
    Z-0383-2018
    Event Number
    78802
    Firm
    TEI Biosciences
    FEI Number
    3004170064
    Product Code
    KGN
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 15, 2017
    Terminated
    March 15, 2018
    Address
    7 Elkins St, Boston, MA, 02127-1601

    Description

    PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

    Reason

    During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.

    Action

    Integra LifeSciences Corporation notified (all U.S.) customers via Letter/Medical Device Correction Field Safety Notice dated June 15, 2017. Letter delivered by courier service, facsimile or email July 15, 2017.

    Distribution

    U.S.

    Quantity

    4081 units