FDA recall Z-2416-2019

Product

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.

Reason for recall

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

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2019-07-25

Report date

2019-09-04

Termination date

2020-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2416-2019