FDA-Device2013-08-07Class I
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
DePuy Orthopaedics, Inc.
Hazard
The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.
Sold states
Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NC, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.
Affected count
58 U.S. / 39 OUS
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1820-2013Don't want to check this manually?
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