Z-2414-2019 Class II Terminated
FDA device recall Z-2414-2019 was initiated by Stryker GmbH on July 25, 2019 and is designated Class II. Reason for recall: The seal integrity of the sterile bag containing the kits may be compromised. The recall status is terminated (terminated September 24, 2020). Affected quantity: 53.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2019
- Initiation Date
- July 25, 2019
- Termination Date
- September 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53
Product Description
Endotrac ECTR Triangle Blade, Catalog Number 2054-1 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.
Reason for Recall
The seal integrity of the sterile bag containing the kits may be compromised.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Number 01407