FDAFDA · Food and drugs·Recall number Z-2416-2019
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 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.
Published September 4, 2019 · Recall initiated: July 25, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The seal integrity of the sterile bag containing the kits may be compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker GmbH
- Distributor
- US Nationwide Distribution
- Lot
- Lot Numbers 01399, 01464, 01477
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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