Home › Device types › LYC
Bone Grafting Material, Synthetic
FDA product code LYC · Class 2 · Dental
994
Registered devices
505
Adverse events
14
Recalls
231
510(k) clearances
Devices with this code
Actifuse Granules — Apatech LtdOsOpia — RevisiOs B.V.Cytoplast™ PTFE Suture — Osteogenics Biomedical IncSteinerBio — STEINER BIOTECHNOLOGY LLC.Maxresorb — CERAMISYS LTDMBCP — BIOMATLANTEOsOpia — RevisiOs B.V.Actifuse Microgranules — Apatech LtdCytoplast™ PTFE Suture — Osteogenics Biomedical IncCytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced — Osteogenics Biomedical IncOsteonIII — GENOSS CO., Ltd.Newport Biologics Bone Graft Putty Mineral Collagen Composite — Prismatik Dentalcraft, IncOSSEOGUARD® — ZimVie US Corp LLCImplant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules — CYTOPHIL, INC.OSTEON II — GENOSS CO., Ltd.SteinerBio — STEINER BIOTECHNOLOGY LLC.Dental Porous Morsels 2x1.5g — NOVABONE PRODUCTS, LLCOSSEOGUARD® — ZimVie US Corp LLCOSTEON II — GENOSS CO., Ltd.GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO.Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced — Osteogenics Biomedical IncBoneMedik-DM, 2~4mm, 5cc — Meta Biomed Co., Ltd.OSSEOGUARD® — ZimVie US Corp LLCOSSEOGUARD® — ZimVie US Corp LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-16 | Collagen Matrix, Inc. | There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend |
| 2016-09-07 | Osteogenics Biomedical, Inc. | The device has the potential to be packaged in the wrong product box. |
| 2016-01-21 | Biomet France SARL | Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/inj |
| 2013-10-03 | Biomet 3i, LLC | Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number. |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the produc |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the produc |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the produc |
| 2012-10-25 | Kerr Corporation | The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. |
| 2012-01-11 | Cytophil, Inc | Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped a |
| 2010-05-14 | Ace Surgical Supply Co., Inc. | Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then |
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