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Recall Observatory FDA recall evidence

Device product

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Z-0884-2021

November 09, 2020

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 86760
Status
Ongoing
Classification
Class II
Quantity
14 devices
Official record key
device-enforcement:Z-0884-2021

Official wording

Reason: Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Code information: Catalog 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.

Distribution pattern: Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.