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Matrix Surgical Holdings, LLC recalls OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and ana
Recalled May 8, 2019 · FDA recall Z-1223-2019 · Matrix Surgical Holdings
Hazard
Product mislabeling. · FDA Class II
Units
46
Sold at
Worldwide distribution - US Nationwide distribution in the states of Florida and Massachusetts and countries of Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey.
Description
Product mislabeling.
Product
OMNIPORE Surgical Implant Petite Paranasal - Left - 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.
Manufacturer(s)
Matrix Surgical Holdings, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →