Device product
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 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.
Z-2417-2019
Product summary
- Firm
- Stryker GmbH
- Event
- Event 83423
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1533
- Official record key
device-enforcement:Z-2417-2019
Official wording
Reason: The seal integrity of the sterile bag containing the kits may be compromised.
Code information: Lot Numbers 01398, 01465, 01481
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Sterility assurance
sterile bag containing the kits may be compromised