FDA recall Z-1224-2019

Matrix Surgical Holdings, LLC · Class II · device

Product

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.

Reason for recall

Product mislabeling.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-01-30
Report date
2019-05-08
Termination date
2020-06-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1224-2019