Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: Recalled by Matrix Surgical Holdings, LLC Due to Mislabeling

Date: January 30, 2019
Company: Matrix Surgical Holdings, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Matrix Surgical Holdings, LLC directly.

Affected Products

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.

Quantity: 46

Why Was This Recalled?

Product mislabeling.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Matrix Surgical Holdings, LLC

Matrix Surgical Holdings, LLC has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report