BEUDAMED
    FDA Enforcement Class II Ongoing

    Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.

    Recall: Z-2084-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2084-2023
    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

    Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 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): 611-005-001 (10381780357308), 611-005-002 (10381780357315).

    Distribution

    Domestic: Nationwide Distribution.

    Quantity

    665 units