Instratek Recalls Angled Hook Blades for Endoscopic Tarsal Tunnel Decompression
Instratek is recalling 39 sterile angled hook blades that do not fit into the handle of the Endoscopic Tarsal Tunnel Decompression system.
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. The hazard is a functional defect (blade does not fit handle) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Instratek, Incorporated is recalling 39 units of the Hook Blade, Angled (Part number 7058A). These sterile disposable blades are intended for use with the Endoscopic Tarsal Tunnel Decompression (ETTD) System. The recall involves Lot number MDHZ620.
The recall was initiated because the sterile blade will not fit into the handle provided with the ETTD system. This defect prevents the device from being used as intended.
The affected products were distributed in the United States to the states of Texas, Utah, New York, and Colorado. Consumers and healthcare providers should stop using the affected blades and contact Instratek, Incorporated for further instructions.
The recalled product
- Product
- Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
- Manufacturer
- Instratek, Incorporated
- Hazard
- Affected units
- 39
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 MDHZ620
Distribution
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