BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1777-2022
    Event ID
    90783
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Collagen Matrix Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    August 3, 2022
    Classification Date
    September 23, 2022
    Address
    15 Thornton Rd, N/A, Oakland, NJ, 07436-3115, United States

    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.

    Code Info

    1) UDI (1 unit package): +D765RTMTAPE100/$$3250131E1C0070AJ; (10 units package): +D765RTMTAPE101/$$3250131E1C0080AK Cytoplast RTMTAPE, Lot E1C0070A 2) UDI (1 unit package): (01)00366975012616(17)250131(10)BDDWTU211002; (10 units package): (01)10366975012613(17)250131(10)BDDWTU211002 GIBSON Healthcare, REF 5251-194; Lot BDDWTU211002 3) UDI (1 unit package): (01)00813954023571(17)250131(10)BDDWTU211002; (10 units package): (01)10813954023578(17)250131(10)BDDWTU211002 MaxxTape, Ref: XTAPE; Lot BDDWTU211002 4) UDI (1 unit package): (01)00813954022079(17)250131(10)BDDWTU211002; (5 units package): (01)10813954022076(17)250131(10)BDDWTU211002 NEOTAPE, Lot BDDWTU211002 5) UDI (1 unit package): (01)00842517100084(17)250131(10)BDDWTU211002; (10 units package): (01)00842517100077(17)250131(10)BDDWTU211002 Karl Schumacher Dental, REF RCWT0001; Lot BDDWTU211002

    Distribution

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

    Quantity

    1336 units