FDA-Device2015-01-14Class II
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
Exactech, Inc.
Hazard
Mislabeled
Sold states
International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
Affected count
96
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0906-2015Don't want to check this manually?
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