CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report
Endotrac ECTR Triangle Blade recalled by Stryker
Stryker is recalling Endotrac ECTR Triangle Blade, distributed nationwide in the US. The recall was initiated on 25 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2414-2019
- FDA event ID
- 83423
- Recalling firm
- Stryker, Selzach, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2019
- FDA classified
- 27 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 25 Jul 2019 | Recall initiated by company | |
| 27 Aug 2019 | Classified by FDA | +33 days |
| 4 Sep 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The seal integrity of the sterile bag containing the kits may be compromised.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Endotrac ECTR Triangle Blade, Catalog Number 2054-1 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Endotrac ECTR Triangle Blade recalled?
Yes. Stryker recalled Endotrac ECTR Triangle Blade on 25 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2414-2019.
Why was it recalled?
The seal integrity of the sterile bag containing the kits may be compromised.
Which lots are affected?
Lot Number 01407
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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