FDA-Device2021-12-22Class II
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Smith & Nephew, Inc.
Hazard
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Sold states
US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
Affected count
35 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0365-2022Don't want to check this manually?
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