Biom'up: Medical Device Recall in 2017 - (Recall #: Z-1110-2017)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2017.
Data Source: FDA.
Product Description:
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
Product Classification:
Class II
Date Initiated: December 2, 2016
Date Posted: February 8, 2017
Recall Number: Z-1110-2017
Event ID: 76319
Reason for Recall:
Lack of sterility assurance
Status: Terminated
Product Quantity: 1,682 units
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
Distribution Pattern:
Distributed to a sole distributor in NC.
Voluntary or Mandated:
Voluntary: Firm initiated