BEUDAMED
    FDA Enforcement Class II Ongoing

    PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).

    Recall: Z-2079-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2079-2023
    Event ID
    92481
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TEI Biosciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2023
    Initiation Date
    May 23, 2023
    Classification Date
    July 3, 2023
    Address
    7 Elkins St, N/A, Boston, MA, 02127-1601, United States

    Description

    PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).

    Reason

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Code Info

    Item No. (UDI-DI): 607-005-225 (10381780113423), 607-005-330 (10381780113430), 607-005-440 (10381780113447), 607-005-550 (10381780113454), 607-005-660 (10381780113461), 607-005-812 (10381780113478), 607-005-880 (10381780113485).

    Distribution

    Domestic: Nationwide Distribution.

    Quantity

    33,277 units