FDA-Device2013-12-11Class II
GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, 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
16 pieces
Manufactured in
1450 E. Brooks Rd, N/A, Memphis, TN, United States
Products
GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0444-2014Don't want to check this manually?
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