FDA-Device2014-05-21Class II
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Ortho Development Corporation
Hazard
A femoral component containing pegs was found in a box for the pegless version.
Sold states
US Nationwide Distribution in the states of NV, and AZ.
Affected count
5
Manufactured in
12187 Business Park Dr, Draper, UT, United States
Products
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1610-2014Don't want to check this manually?
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