Recall Z-0113-2017
Osteogenics Biomedical, Inc. · initiated September 7, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot 47295
Reason for recall
The device has the potential to be packaged in the wrong product box.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0113-2017
- Initiated
- September 7, 2016
- Terminated
- December 23, 2016
- Product code
- LYC – Bone Grafting Material, Synthetic
- Quantity
- 32 boxes
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
- Recalling firm
- Osteogenics Biomedical, Inc., Lubbock, TX