FDA-Device2023-11-08Class II
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Corin Ltd
Hazard
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Sold states
US: MI, TX, IL
Affected count
1 units
Manufactured in
Unit 1-57-8, Corinium Centre, Cirencester, N/A, United Kingdom
Products
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0214-2024Don't want to check this manually?
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