Recall Z-1224-2019— Matrix Surgical Holdings, LLC

Name: FDA recall Z-1224-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-30

Class II · Terminated

Class II FDA medical device recall by Matrix Surgical Holdings, LLC, initiated 2019-01-30, terminated 2020-06-23. It names one FDA 510(k) clearance: K123908. 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: Product mislabeling..

Recalling firm: Matrix Surgical Holdings, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-01-30
Terminated: 2020-06-23
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K123908 — OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USA·cleared 2013-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Product mislabeling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.