RENOVIX Guided Healing Collagen Membrane Intended for recall: Sterility Concern
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
Why was RENOVIX Guided Healing Collagen Membrane Intended for recalled?
Lack of sterility assurance
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
- Recalling firm
- Biom'up
- Quantity
- 1,682 units
- Distribution
- Distributed to a sole distributor in NC.
- Recall date
- February 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)