Stryker Recalls 2.5MM Aggressive Sinuscopic Shaver Blades Due to Missing Scale
Stryker is voluntarily recalling 90 units of 2.5MM Aggressive Sinuscopic Shaver Blades because the etched line guide is missing the required 1cm to 7cm number scale.
What this means for you
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 involves a missing measurement scale on a surgical device. This is a labeling/defect issue that could lead to improper use, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling 90 units of the 2.5MM Aggressive Blade, also known as a Sinuscopic Shaver Blade. The affected devices are identified by Part Number 5290-628-000 and Lot Number 13280CG2. These single-use devices are used for ENT procedures and function by rotating to resect tissue when adapted to a handpiece and console.
The recall is being conducted because the line on the affected part was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm to 7cm in 1cm increments, which serves as a guide for the doctor to indicate how far the device is being introduced into the surgical area.
The affected units were distributed in the United States to the states of Nevada, California, Washington, Tennessee, Oregon, South Dakota, Idaho, Indiana, and Colorado, as well as internationally to Malaysia. Healthcare providers and facilities should stop using the affected blades and contact Stryker Instruments for further instructions.
The recalled product
- Product
- 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 90
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)
- P/N 5290-628-000
- Lot #13280CG2
Distribution
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