BEUDAMED
    FDA Enforcement Class II Ongoing

    PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).

    Recall: Z-2078-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2078-2023
    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 Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 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): 607-004-440 (10381780113379), 607-004-660 (10381780113386), 607-004-880 (10381780113393), 607-005-014 (10381780357414), 607-005-018 (10381780357421), 607-005-125 (10381780113409), 607-005-220 (10381780357407).

    Distribution

    Domestic: Nationwide Distribution.

    Quantity

    30,528 units