Class II — Osteogenics Biomedical, Inc.
| Recalling firm | OSTEOGENICS BIOMEDICAL, INC. |
|---|---|
| Registered facility | OSTEOGENICS BIOMEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device has the potential to be packaged in the wrong product box. |
| 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. |
| Quantity | 32 boxes |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK. |
| Initiated | 2016-09-07 |
| Classified | 2016-10-18 |
| Terminated | 2016-12-23 |
| Recall number | Z-0113-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Osteogenics Biomedical, Inc. (Z-0113-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75119/
Alerts for OSTEOGENICS BIOMEDICAL, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.