Stryker Recalls Specific Lots of Round Fluted Burs Due to Corrosion
Stryker is voluntarily recalling specific lots of 6.0mm Round Fluted Burs due to potential tarnishing or corrosion that could cause inflammation requiring surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (foreign body reaction necessitating surgical intervention) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker Instruments Division of Stryker Corporation has initiated a voluntary recall of specific lots of 6.0mm Round Fluted Burs, Super Long. The recall involves 25 units identified by code 5190-010-060 and lot numbers 15231017, 16033017, and 16066017.
The recall is being conducted because the burs may exhibit tarnishing or corrosion. This condition could result in a foreign body reaction, specifically inflammation, which may necessitate surgical intervention.
The affected products were distributed in the United States to California, Illinois, and South Dakota, as well as to Canada and the Netherlands. Healthcare professionals and patients who have used these specific lots should contact Stryker Instruments for further instructions on how to proceed.
The recalled product
- Product
- 6.0mm Round Fluted Bur, Super Long
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 25
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 (3)
- 5190-010-060 Lot Numbers 15231017
- 16033017
- 16066017
Distribution
Part of a larger recall action
This product is one of 2 recalled by Stryker Instruments Div. of Stryker Corporation 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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