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Exactech, Inc. recalls Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Recalled January 27, 2021 · FDA recall Z-0884-2021 · Exactech
Hazard
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. · FDA Class II
Units
14 devices
Sold at
Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
Description
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Product
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →