BEUDAMED
    FDA Enforcement Class III Terminated

    BioMend Extend, REF# 0142Z, Synthetic bone grafting material.

    Recall: Z-0414-2019 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0414-2019
    Event ID
    81282
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Collagen Matrix, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2018
    Initiation Date
    August 16, 2018
    Classification Date
    November 9, 2018
    Termination Date
    June 23, 2020
    Address
    110 Commerce Dr, Allendale, NJ, 07401-1622, United States

    Description

    BioMend Extend, REF# 0142Z, Synthetic bone grafting material.

    Reason

    There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.

    Code Info

    CDMEN18F1, CDMEN18F3

    Distribution

    Distributed to one distributor located in Florida.

    Quantity

    569