BEUDAMED
    FDA Enforcement Class II Terminated

    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

    Recall: Z-2145-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2145-2019
    Event ID
    82636
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Geistlich Pharma North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    April 12, 2019
    Classification Date
    August 2, 2019
    Termination Date
    October 21, 2020
    Address
    202 Carnegie Ctr Ste 103, N/A, Princeton, NJ, 08540-6239, United States

    Description

    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

    Reason

    When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

    Code Info

    Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.

    Distribution

    US Nationwide distribution.

    Quantity

    244,268 total