FDA-Device2022-01-19Class II
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
DePuy Orthopaedics, Inc.
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
Sold states
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.
Affected count
3 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0485-2022Don't want to check this manually?
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