Osteogenics Recalls Cytoplast Membrane Due to Packaging Error
Osteogenics Biomedical, Inc. is recalling 32 boxes of Cytoplast Titanium-Reinforced Posterior Singles Membrane because the device may be packaged in the wrong product box.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging-only problem (wrong product box) with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or documentation issues.
Plain-English summary
Osteogenics Biomedical, Inc. is recalling 32 boxes of Cytoplast Titanium-Reinforced Posterior Singles Membrane. This product is a temporarily implantable, non-resorbable material used as a space-making barrier in the treatment of periodontal bone defects.
The recall was initiated because the device has the potential to be packaged in the wrong product box. The affected product is identified by Lot 47295.
The product was distributed worldwide, including in the United States, Colombia, Venezuela, Ecuador, Japan, India, Canada, and the United Kingdom. No specific instructions for consumers are provided in the source text.
The recalled product
- 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.
- Manufacturer
- Osteogenics Biomedical, Inc.
- Hazard
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 47295
Distribution
Distribution scope not specified by the agency.
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