Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0884-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Product Classification:

Class II

Date Initiated: November 9, 2020

Date Posted: January 27, 2021

Recall Number: Z-0884-2021

Event ID: 86760

Reason for Recall:

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

Status: Ongoing

Product Quantity: 14 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated