Matrix Surgical Holdings product recalled over labeling errors

Recall date

January 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Matrix Surgical Holdings, LLC recalls OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

Recall number

Z-1382-2017

FDA classification

Class II

Brand / firm

Matrix Surgical Holdings, LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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