BEUDAMED
    FDA Enforcement Class III Terminated

    Porcine Anorganic Bone Mineral 4.0cc

    Recall: Z-0752-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0752-2019
    Event ID
    81626
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Collagen Matrix Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2019
    Initiation Date
    October 30, 2018
    Classification Date
    January 17, 2019
    Termination Date
    May 12, 2020
    Address
    15 Thornton Rd, Oakland, NJ, 07436-3115, United States

    Description

    Porcine Anorganic Bone Mineral 4.0cc

    Reason

    There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.

    Code Info

    UDI - (01)00813954022369(17)210430(10)PMCU18C4 Lot Number - PMCU18C4 Expiration Date - 04/30/2021

    Distribution

    FL, TX

    Quantity

    136 units