Home / Recalls / Medical Devices
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Recalled January 19, 2022 · FDA recall Z-0486-2022 · DePuy Orthopaedics
Hazard
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 · FDA Class II
Units
781 units
Sold at
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.
Description
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
Product
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →