FDA-Device2022-07-27Class II
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Smith & Nephew, Inc.
Hazard
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
Sold states
US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI.
Affected count
31 devices
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1418-2022Don't want to check this manually?
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