BEUDAMED
    FDA Enforcement Class II Ongoing

    SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.

    Recall: Z-2071-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2071-2023
    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 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.

    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): 606-005-003 (10381780112952) and 606-005-004 (10381780112969).

    Distribution

    Domestic: Nationwide Distribution.

    Quantity

    52 units