FDA-Device2014-10-29Class II

Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).

Signal Medical Corporation
Hazard

Packaging of a device was compromised

Sold states
Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
Affected count
41
Manufactured in
400 Pyramid Dr, Marysville, MI, United States
Products
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0111-2015

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