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DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Recalled January 19, 2022 · FDA recall Z-0485-2022 · 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
3 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 REV STEM SZ 8 Part Number: 110008600
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →