Class 2 Device Recall RENOVIX Guided Healing Collagen Membrane

• Date Initiated by Firm: December 02, 2016
• Date Posted: January 27, 2017
• Recall Status: Terminated 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: 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