The Recall Desk
ModerateFDA (Devices)·Z-2424-2019·Announced 2019-09-04

Stryker Recalls Endintrak 2 Hook Blade Kits Due to Seal Integrity

Stryker GmbH is recalling 259 Endintrak 2 Hook Blade kits because the sterile bag seal integrity may be compromised, potentially affecting sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Stryker GmbH is recalling 259 units of the Endintrak 2 Hook Blade, Angled (Catalog Number 4058A-1). The recall affects Lot Numbers 01405 and 01479, which were distributed nationwide in the United States. The product is part of a system designed for the minimally invasive surgical treatment of chronic plantar fasciitis and gastrocnemius equinus.

The recall was initiated because the seal integrity of the sterile bag containing the kits may be compromised. This defect could potentially affect the sterility of the surgical instruments.

Healthcare providers and patients who have used or possess these specific lots should contact Stryker GmbH for further instructions on how to proceed.

The recalled product

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 gast
Manufacturer
Stryker GmbH
Category
Medical Device — Surgical Instruments
Hazard
Affected units
259

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number 01405
  • 01479

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Stryker GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same manufacturer · Stryker GmbH

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Same hazard · sterility compromise

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