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Exactech, Inc. Recall 86760

Description: Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Exactech, Inc. Recall 86760 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0884-2021
Event ID86760
Event DescriptionEquinoxe Humeral Stem, Primary, Press Fit, 11mm
Product TypeDevices
DistributionDistributed within the US to KS, OH, CA. International distribution to Australia and Germany.
Quantity14 devices
Recall ReasonPotential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Device Classification20210127
Device Code InfoCatalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, and 6477407.
Center Classification Date20210121
Recall Initiation Date20201109
Recalling FirmExactech, Inc.
Initial Notification E-Mail
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