BIOPLANT

  • Modèle / numéro de série
    Model Catalog: 216112 (Lot serial: 216132 - H005876 (12 syringes)); Model Catalog: 216132 (Lot serial: 216112 - 2685295 (18 syringes)); Model Catalog: 216112 (Lot serial: 216132 - 2685297 (4 syringes)); Model Catalog: 216132 (Lot serial: 216132 - 2685297 (4 syringes)); Model Catalog: 216112 (Lot serial: 216132 - 2649171 (4 syringes)); Model Catalog: 216132 (Lot serial: 216132 - 2649171 (4 syringes)); Model Catalog: 216132 (Lot serial: 216112 - 2720970 (6 syringes)); Model Catalog: 216132 (Lot serial: 216132 - H005876 (12 syringes)); Model Catalog: 216112 (Lot serial: 216132 - 2746762 (4 syringes)); Model Catalog: 216132 (Lot serial: 216132 - 2746762 (4 syringes)); Model Catalog: 216112 (Lot serial: 216132 - 2720971 (4 syringes)); Model Catalog: 216132 (Lot serial: 216132 - 2720971 (4 syringes)); Model Catalog: 216112 (Lot serial: 216112 - 2763764 (18 syringes)); Model Catalog: 216132 (Lot serial: 216112 - 2763764 (18 syringes)); Model Catalog: 216112 (Lot serial: 216112 - 2763763 (6 syringes)); Model Catalog
  • Description du dispositif
    Bioplast
  • Manufacturer
  • 1 Event

Fabricant

5 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Model: Part Numbers 216110 (0.125g), 216112, (0.25g), 216114 (0.50g), 216132 (2x0.25g), Affected: All lots with expiration dates up to and including Oct-2017
  • Manufacturer
  • Modèle / numéro de série
    Model: Part number 216112B, Affected: All lots with expiration date up to and including Oct-2017
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 216112 (Lot serial: All Lots); Model Catalog: 216114 (Lot serial: All Lots); Model Catalog: 216110 (Lot serial: All Lots); Model Catalog: 216112B (Lot serial: All Lots); Model Catalog: 216132 (Lot serial: All Lots)
  • Description du dispositif
    BIOPLANT
  • Manufacturer
  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
  • Description du dispositif
    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.
  • Manufacturer
  • Modèle / numéro de série
    BioPlant Curved Syringe, multiple doses, BioPlant Intro Pack (synthetic dental bone grafts)BioPlant Curved Syringe 0.125gPart Number: 216110BioPlant Curved Syringe 0.25gPart Number: 216112BioPlant Curved Syringe 0.50gPart Number: 216114BioPlant Curved Syringe 0.25g (2 pack)Part Number; 216132BioPlant Intro PackPart Number: 216112B(Synthetic dental bone grafts)All production lots within shelf lifeARTG Number: 121686
  • Manufacturer