BEUDAMED
    FDA Enforcement Class II Ongoing

    SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.

    Recall: Z-2073-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2073-2023
    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

    SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.

    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): 606-206-001 (10381780357339), 606-206-002 (10381780357360), 606-206-003 (10381780357346), 606-206-004 (10381780357353), 606-206-005 (10381780357377), 606-206-006 (10381780357384), and 606-206-007 (10381780357391).

    Distribution

    Domestic: Nationwide Distribution.

    Quantity

    3,992 units