Matrix Surgical Holdings product recalled over labeling errors

Recall date

January 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Matrix Surgical Holdings, LLC recalls OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and ana…

Recall number

Z-1224-2019

FDA classification

Class II

Brand / firm

Matrix Surgical Holdings, LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of Florida and Massachusetts and countries of Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey.

Why it was recalled

Product mislabeling.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.