Exactech, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0307-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

Product Classification:

Class II

Date Initiated: September 25, 2020

Date Posted: November 4, 2020

Recall Number: Z-0307-2021

Event ID: 86590

Reason for Recall:

The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

Status: Terminated

Product Quantity: 25 devices

Code Information:

Catalog: 304-21-07; Serial Ranges: 4968615-4968627; 4952421-4952432

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.

Voluntary or Mandated:

Voluntary: Firm initiated