RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
FDA device recall Z-1110-2017 · posted 2017-01-27 · Terminated
Recall details
- Recalling firm
- Biom'up
- Reason for recall
- Lack of sterility assurance
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NPL
- Quantity affected
- 1,682 units
- Distribution
- Distributed to a sole distributor in NC.
- Date initiated
- 2016-12-02
- Date posted
- 2017-01-27
- Date terminated
- 2017-05-05
- Location
- St Priest, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COVAMAX RESORBABLE COLLAGEN MEMBRANE (K103087) | Biom'Up Sas | 2011-08-26 |