BEUDAMED
    FDA Enforcement Class II Ongoing

    SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.

    Recall: Z-2074-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2074-2023
    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 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.

    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): 606-300-002 (10381780113072), 606-300-004 (10381780113089) 606-300-006 (10381780113096), 606-300-008 (10381780113102), 606-300-009 (10381780113119), 606-300-016 (10381780113126), 606-300-017 (10381780113133), 606-300-019 (10381780113140), 606-300-020 (10381780113157), 606-300-021 (10381780113164), 606-300-022 (10381780113171), 606-304-001 (10381780113188), and 606-304-002 (10381780113195).

    Distribution

    Domestic: Nationwide Distribution.

    Quantity

    13,390 units