BEUDAMED
    FDA Enforcement Class II Ongoing

    NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

    Recall: Z-0823-2022 · Reported March 30, 2022

    Enforcement

    Recall Number
    Z-0823-2022
    Event ID
    89721
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ace Surgical Supply Co., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 30, 2022
    Initiation Date
    February 2, 2022
    Classification Date
    March 24, 2022
    Address
    1034 Pearl St, N/A, Brockton, MA, 02301-5411, United States

    Description

    NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

    Reason

    NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair

    Code Info

    Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.

    Quantity

    31 eaches