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.
FDA Recall Z-0113-2017 · Posted None
Recalling FirmOsteogenics Biomedical, Inc.
Recall StatusTerminated
Product CodeLYC
Date Initiated2016-09-07
Date Terminated2016-12-23
Product Quantity32 boxes
Reason for Recall
The device has the potential to be packaged in the wrong product box.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.