FDA-Device2019-02-20Class II

Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component

Signature Orthopedics Pty Limited
Hazard

Product mix up

Sold states
US Nationwide Distribution in the states of FL, NY, and TN
Affected count
3
Manufactured in
Lane Cove W, 7 Sirius Rd, Lane Cove West, N/A, Australia
Products
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0834-2019

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