Device recall
Z-0113-2017: Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily…
FDA device recall · Class II · Osteogenics Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0113-2017 |
|---|---|
| Recall event | 75119 |
| Product | 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. |
| Product code | LYC |
| Recalling firm | Osteogenics Biomedical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 23, 2016 |
| 510(k) numbers | K972278 |
| FEI number | 3002253367 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database