Recall Z-0113-2017 ยท LYC Bone Grafting Material, Synthetic
Osteogenics Biomedical, Inc.
Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
| Date | Sep 7, 2016 |
| Status | Terminated |
| Reason | The device has the potential to be packaged in the wrong product box. |
| Root cause | Labeling mix-ups |
| Action | Osteogenics Biomedical sent an Urgent Customer Notification letter dated September 7, 2016, to all affected customers. This recall has been extended to the user level (clinician). All units sold domestically were to the end users (clinicians). End users were instructed to inspect inventory and return any affected product. For further questions, please call 1-888- 796-1923. |
| Quantity | 32 boxes |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972278 | CYTOPLAST REGENTEX TITANIUM 250 Osteogenics Co., Aug 6, 1997 |