FDA (Devices) recall action 83423

Stryker GmbH recalled 13 products on 2019-09-04

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products: 13
Announced: 2019-09-04
Critical: 0
Units: 7,143

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–13 of 13

ModerateFDA (Devices)··2019-09-04
Stryker Recalls Endotrig ETF Hook Blades Due to Sterile Seal Concerns
Stryker GmbH is recalling 35 Endotrig ETF Hook Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.
Product
Endotrig ETF Hook Blade, Catalog Number 1052-1 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
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0 states
ModerateFDA (Devices)··2019-09-04
Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal
Stryker GmbH is recalling 110 units of Endotrac EPF/EGR Hook Blades because the sterile bag seal integrity may be compromised.
Product
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-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
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0 states
ModerateFDA (Devices)··2019-09-04
Stryker Endotrac Triangle Blade Recall Due to Compromised Sterile Bag Seal
Stryker GmbH is recalling 1,533 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.
Product
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 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 gastr
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0 states
HighFDA (Devices)··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.
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
Category
Distribution
0 states
ModerateFDA (Devices)··2019-09-04
Stryker Recalls Endotrac ECTR Triangle Blades Due to Seal Integrity
Stryker GmbH is recalling 94 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.
Product
Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-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
Category
Distribution
0 states
HighFDA (Devices)··2019-09-04
Stryker Endotrac EPF/EGR Triangle Blade Recall for Compromised Sterile Seal
Stryker GmbH is recalling 21 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, posing a risk of contamination.
Product
Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-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
Category
Distribution
0 states
ModerateFDA (Devices)··2019-09-04
Stryker Recalls Endotrac ECTR Hook Blades Due to Seal Integrity Concerns
Stryker GmbH is recalling 1,959 Endotrac ECTR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.
Product
Endotrac ECTR Hook Blade, Catalog Number 2055-1 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 gastrocnemiu
Category
Distribution
0 states
ModerateFDA (Devices)··2019-09-04
Stryker Endotrac Push Blade Recalled for Compromised Sterile Bag Seal
Stryker GmbH is recalling 251 Endotrac EPF/EGR Push Blades because the sterile bag seal integrity may be compromised.
Product
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 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 gastrocne
Category
Distribution
0 states
ModerateFDA (Devices)··2019-09-04
Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal
Stryker GmbH is recalling 2,248 Endotrac EPF/EGR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.
Product
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 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 gastrocne
Category
Distribution
0 states
ModerateFDA (Devices)··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.
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
Category
Distribution
0 states
HighFDA (Devices)··2019-09-04
Stryker Endotrac ECTR Push Blade Recalled for Sterile Bag Seal Integrity
Stryker GmbH is recalling 476 Endotrac ECTR Push Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.
Product
Endotrac ECTR Push Blade, Catalog Number 2053-1 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 gastrocnemiu
Category
Distribution
0 states
ModerateFDA (Devices)··2019-09-04
Stryker Endotrac ECTR Triangle Blade Recalled Due to Compromised Sterile Bag Seal
Stryker GmbH is recalling 53 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.
Product
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 gastrocn
Category
Distribution
0 states
ModerateFDA (Devices)··2019-09-04
Stryker Recalls Endotrac ECTR Hook Blade Kits Due to Seal Integrity
Stryker GmbH is recalling 28 Endotrac ECTR Hook Blade kits because the sterile bag seal integrity may be compromised.
Product
Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-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 gas
Category
Distribution
0 states