Z-1110-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2017
- Initiation Date
- December 2, 2016
- Termination Date
- May 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,682 units
Product Description
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
Reason for Recall
Lack of sterility assurance
Distribution Pattern
Distributed to a sole distributor in NC.
Code Information
Lot Numbers: MCG16003.133034 MCG16003.133035 MCG16003.133036 MCG16003.133037 MCG16003.133038 MCG16003.133172 MCG16003.133173 MCG16003.133174 MCG16003.133251 MCG16003.133252 MCG16003.133253 MCG16003.133254