Arthrex, Inc. recalls Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and…

Recall date

March 11, 2021

Source

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

Recall number

Z-1380-2021

FDA classification

Class II

Brand / firm

Arthrex, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.

Why it was recalled

It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

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

What was recalled

Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.