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.
Recall
- Recall Number
- Z-0113-2017
- Event Number
- 75119
- Firm
- Osteogenics Biomedical, Inc.
- FEI Number
- 3002253367
- Product Code
- LYC
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- September 7, 2016
- Terminated
- December 23, 2016
- Address
- 4620 71st St, Bldg 75-77, Lubbock, TX, 79424-2230
Description
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.
The device has the potential to be packaged in the wrong product box.
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.
Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
32 boxes