Z-0113-2017 Class II Terminated
FDA device recall Z-0113-2017 was initiated by Osteogenics Biomedical, Inc. on September 7, 2016 and is designated Class II. Reason for recall: The device has the potential to be packaged in the wrong product box. The recall status is terminated (terminated December 23, 2016). Affected quantity: 32 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2016
- Initiation Date
- September 7, 2016
- Termination Date
- December 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 boxes
Product 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.
Reason for Recall
The device has the potential to be packaged in the wrong product box.
Distribution Pattern
Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
Code Information
Lot 47295