FDA Device

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.

Hazard

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

What You Should Do

Remedy

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.

Products

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.
Brand
Osteogenics Biomedical, Inc.
UPC
Lot 47295

Units Affected

32 boxes