BEUDAMED
    FDA Enforcement Class II Terminated

    BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.

    Recall: Z-0401-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0401-2013
    Event ID
    63557
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kerr Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    October 25, 2012
    Classification Date
    November 20, 2012
    Termination Date
    September 23, 2013
    Address
    1717 W Collins Ave, N/A, Orange, CA, 92867-5422, United States

    Description

    BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.

    Reason

    The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.

    Code Info

    The BioPlant part numbers and lot numbers affected by this recall are as follows: Product Description Part Numbers Lot Numbers BioPlant Curved Syringe, 0.125g 216110 All Production BioPlant Curved Syringe, 0.25g 216112 BioPlant Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life BioPlant Curved Svrinoe, 0.250 216132 20k BioPlant Intro Pack 216112S

    Distribution

    Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .

    Quantity

    22,410 units