RENOVIX Guided Healing Collagen Membrane Intended for use in oral… — Class II medical device recall Z-1110-2017
Terminated recall by Biom'up, reported 2017-02-08, distributed in NC. Lack of sterility assurance
| Recall number | Z-1110-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biom'up, St Priest, N/A, France |
| Recall initiated | 2016-12-02 |
| Classified | 2017-01-27 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-05-05 |
| Distributed | NC |
| Quantity | 1,682 units |
| Reason classes | sterility |
| 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.
Reason for recall
Lack of sterility assurance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1110-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.