Recall Z-2424-2019— Stryker GmbH
Class II · Terminated
Class II FDA medical device recall by Stryker GmbH, initiated 2019-07-25, terminated 2020-09-24. It names one FDA 510(k) clearance: K940230. Product: Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-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: The seal integrity of the sterile bag containing the kits may be compromised..
- Recalling firm
- Stryker GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-25
- Terminated
- 2020-09-24
- Firm location
- Selzach, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.