FDA-Device2020-11-04Class II
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Exactech, Inc.
Hazard
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Sold states
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.
Affected count
25 devices
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0307-2021Don't want to check this manually?
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