Stryker GmbH recalls Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar…

Recall date

July 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2422-2019

FDA classification

Class II

Brand / firm

Stryker GmbH

Sold / distributed

US Nationwide Distribution

Why it was recalled

The seal integrity of the sterile bag containing the kits may be compromised.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.