Matrix Surgical Holdings, LLC: Medical Device Recall in 2019 - (Recall #: Z-1224-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: January 30, 2019
Date Posted: May 8, 2019
Recall Number: Z-1224-2019
Event ID: 82487
Reason for Recall:

Product mislabeling.

Status: Terminated
Product Quantity: 42
Code Information:

OP9520 / Lot # 00855421005871 022050617

Distribution Pattern:

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 or Mandated:

Voluntary: Firm initiated