BEUDAMED
    FDA Recall Open, Classified

    Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm

    Recall: Z-1777-2022 · Initiated August 3, 2022

    Recall

    Recall Number
    Z-1777-2022
    Event Number
    90783
    Firm
    Collagen Matrix Inc
    FEI Number
    3008817245
    Product Code
    KGN
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    August 3, 2022
    Posted
    September 23, 2022
    Address
    15 Thornton Rd, Oakland, NJ, 07436-3115

    Description

    Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm

    Reason

    The packaging may not be sealed, which could compromise sterility.

    Action

    On August 3, 2022, Collagen Matrix began informing the distributors (initial consignees) to place the lot in question on ship hold. On August 8, 2022, Collagen Matrix began informing distributors by email to return the concerned products. Consignees are asked to return any recalled product to the recalling firm and complete the Certificate of Acknowledgement within 15 days of receipt and return it via email.

    Distribution

    US distribution to distributors in IL, IN, MI, NC, OH, and TX

    Quantity

    1336 units