The Recall Desk
HighFDA (Devices)·Z-2419-2019·Announced 2019-09-04

Stryker Endintrak 2 Hook Blade Recall Due to Compromised Sterile Seal

Stryker GmbH is recalling 76 units of the Endintrak 2 Hook Blade because the sterile bag seal may be compromised, potentially affecting sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a compromised sterile seal, which poses a risk of harm (infection) during surgical use, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Stryker GmbH is recalling 76 units of the Endintrak 2 Hook Blade, Catalog Number 4058-1, Lot Number 01412. 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.

The affected products were distributed nationwide in the United States. A compromised sterile seal may allow contamination, posing a risk of infection if the product is used in a surgical procedure. The source text does not report any specific illnesses or injuries associated with this recall.

Healthcare providers and facilities should stop using the affected Endintrak 2 Hook Blade kits immediately. Users should check their inventory for the specific catalog number and lot number listed above. If the product has already been used, or if there are concerns regarding patient safety, contact the recalling firm or the FDA for further instructions.

The recalled product

Product
Endintrak 2 Hook Blade, Catalog Number 4058-1 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
Manufacturer
Stryker GmbH
Category
Medical Device — Surgical Instruments
Hazard
Affected units
76

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 (1)

  • Lot Number 01412

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

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Same hazard · sterility compromise

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