BEUDAMED
    FDA Enforcement Class II Ongoing

    SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm

    Recall: Z-2070-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2070-2023
    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 PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm

    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): 606-004-100 (10381780112822), 606-004-101 (10381780112839), 606-004-102 (10381780112846), 606-004-103 (10381780112853), 606-004-104 (10381780112860), 606-004-105 (10381780112877), 606-004-106 (10381780112884), 606-004-107 (10381780112891), 606-004-108 (10381780112907), 606-004-109 (10381780112914), 606-004-110 (10381780112921), 606-005-001 (10381780112938), 606-005-002 (10381780112945), 606-007-001 (10381780357322).

    Distribution

    Domestic: Nationwide Distribution.

    Quantity

    22,163 units