Device product
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
Z-1110-2017
Product summary
- Firm
- Biom'up
- Event
- Event 76319
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,682 units
- Official record key
device-enforcement:Z-1110-2017
Official wording
Reason: Lack of sterility assurance
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
Distribution pattern: Distributed to a sole distributor in NC.
Derived failure modes
-
Sterility assurance
Lack of sterility