BIOPLANT

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: Part number 216112B, Affected: All lots with expiration date up to and including Oct-2017

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

Bioplast

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

Dental Devices

2

Yes

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

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.

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