Exactech, Inc. recalls Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemen

Recalled November 4, 2020 · FDA recall Z-0307-2021 · Exactech

Hazard

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

Units

25 devices

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Exactech, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →