FDA-Device2022-01-19Class II
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
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
140 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2022Don't want to check this manually?
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