FDA recall Z-0307-2021

Product

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

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-09-25

Report date

2020-11-04

Termination date

2023-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0307-2021