FDA-Device2021-01-27Class II
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Exactech, Inc.
Hazard
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Sold states
Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
Affected count
14 devices
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0884-2021Don't want to check this manually?
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