Class II — Potential Health Hazard

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

OP7543 Design Y Mandible Onlay - Medium - Left and Recalled by Matrix Surgical Holdings, LLC Due to Mislabeling

Date: January 25, 2017
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

OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

Quantity: 28

Why Was This Recalled?

Mislabeling. The packaging labeled as left mandible contained a right mandible.

Where Was This Sold?

Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan

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