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
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)
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
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.