FDA Medical Device Recalls (openFDA)
Biom'up: RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
- Recall number
- Z-1110-2017
- Recalling firm
- Biom'up
- Product
- RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
- Status
- Terminated
- Initiated
- 2016-12-02
- Posted
- 2017-01-27
- Terminated
- 2017-05-05
- Reason
- Lack of sterility assurance
- Root cause
- Nonconforming Material/Component
- Action
- An Urgent Medical Device Recall letter was mailed to affected customer on 12/02/2016 to inform them of the recall. The reason and actions to be taken were explained in the letter. Customer was asked to examine their inventory and contact Biom'Up to arrange for return of product.
- Quantity
- 1,682 units
- Distribution
- Distributed to a sole distributor in NC.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K103087"]
- PMA numbers
- not on file
- Product code
- NPL
- Firm FEI
- 3007702492
- Firm city
- St Priest
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28