Matrix Surgical Holdings, LLC: Medical Device Recall in 2019 - (Recall #: Z-1224-2019)
See the recall detail below. You can also see other recalls from the same firm in 2019.
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
Class II
Product mislabeling.
OP9520 / Lot # 00855421005871 022050617
Worldwide distribution - US Nationwide distribution in the states of Florida and Massachusetts and countries of Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey.
Voluntary: Firm initiated