DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600

Recall date

December 7, 2021

Source

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

Recall number

Z-0487-2022

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

Why it was recalled

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

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

What was recalled

GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600