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U.S. Department of Health and Human Services

Class 2 Device Recall RENOVIX Guided Healing Collagen Membrane

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  Class 2 Device Recall RENOVIX Guided Healing Collagen Membrane see related information
Date Initiated by Firm December 02, 2016
Date Posted January 27, 2017
Recall Status1 Terminated 3 on May 05, 2017
Recall Number Z-1110-2017
Recall Event ID 76319
510(K)Number K103087  
Product Classification Barrier, animal source, intraoral - Product Code NPL
Product RENOVIX Guided Healing Collagen Membrane

Intended for use in oral surgical procedures.
Code Information 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
Recalling Firm/
Manufacturer
Biom'up
Batiment 7
8 allee Irene Joliot Curie
St Priest France
Manufacturer Reason
for Recall
Lack of sterility assurance
FDA Determined
Cause 2
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 in Commerce 1,682 units
Distribution Distributed to a sole distributor in NC.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NPL and Original Applicant = BIOM'UP SAS
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