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Recall Observatory FDA recall evidence

Device 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.

Z-0113-2017

September 07, 2016

Class II

Product summary

Firm
Osteogenics Biomedical, Inc.
Event
Event 75119
Status
Terminated
Classification
Class II
Quantity
32 boxes
Official record key
device-enforcement:Z-0113-2017

Official wording

Reason: The device has the potential to be packaged in the wrong product box.

Code information: Lot 47295

Distribution pattern: Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device has the potential to be packaged in the wrong product box.