FDA Device recall Z-1110-2017
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures by Biom Up, citing lack of sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1110-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-02 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biom Up |
| Distribution | NC |
Product
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
Reason
Lack of sterility assurance
Identifiers
| code_info | Lot Numbers: MCG16003.133034 MCG16003.133035 MCG16003.133036 MCG16003.133037 MCG16003.133038 MCG16003.133172 MCG…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1110-2017%22
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