FDA-Device2013-12-11Class II
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Smith & Nephew Inc
Hazard
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
Sold states
Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.
Affected count
8 pieces
Manufactured in
1450 E. Brooks Rd, N/A, Memphis, TN, United States
Products
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0449-2014Don't want to check this manually?
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