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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker GmbH is recalling 35 units of the Endotrig ETF Hook Blade, Catalog Number 1052-1. The affected units are identified by Lot Numbers 01406 and 01475. These products were distributed nationwide in the United States.
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 medical device. The Endotrig ETF Hook Blade is part of the EPF system, which is designed for the minimally invasive surgical treatment of chronic plantar fasciitis (fasciosis).
Healthcare providers and facilities that have received these specific lot numbers should stop using the affected devices and contact Stryker GmbH for further instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Stryker GmbH
- Hazard
- Affected units
- 35
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 Numbers 01406
- 01475
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.
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