Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2424-2019 — 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.

U.S. FDA — Device Enforcement · Switzerland · 2019-07-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2424-2019
Date of alert: 2019-07-25
Country / jurisdiction: Switzerland
Risk level: Class II
Risk type: recall
Brand: Stryker GmbH
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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