BEUDAMED
    FDA Recall 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 · Initiated October 25, 2012

    Recall

    Recall Number
    Z-0401-2013
    Event Number
    63557
    Firm
    Kerr Corporation
    FEI Number
    2024312
    Product Code
    LYC
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 25, 2012
    Posted
    November 20, 2012
    Terminated
    September 23, 2013
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    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.

    Action

    Kerr Corporation sent an Urgent Medical Device Correction letter and acknowledgement form dated October 25, 2012, to all affected customers via USPS First Class. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: "...review the table with product description , part numbers and lot numbers to determine if they have any of the affected product in their inventory and confirm that they were aware of the additional placement instructions necessary to achieve desired ossification results detailed in the paragraph in the letter. Customers were instructed to contact Kerr Customer Care at 18005377123 if they have any questions. Customers were also instructed to complete and fax back the enclosed Acknowledgement Form to 714-288-4609 in order to confirm their receipt of this correction regardless of whether they have any affected product in their inventory. For questions regarding this recall call 714-516-7400.

    Distribution

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

    Quantity

    22,410 units