Stryker Recalls 5.0mm Round Fluted Burs Due to Corrosion Risk
Stryker Instruments is voluntarily recalling specific lots of 5.0mm Round Fluted Burs because tarnishing or corrosion may 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 involves a risk-of-harm product where the hazard (inflammation necessitating surgical intervention) is a significant medical risk, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation has initiated a voluntary recall of specific lots of 5.0mm Round Fluted Burs, Super Long. The recall involves 25 units of the product, identified by the code 5190-010-050 and Lot Number 15322017.
The recall was initiated due to the potential presence of tarnishing or corrosion on the burs. 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 the states of California, Illinois, and South Dakota, as well as to Canada and the Netherlands. Users of these specific medical devices should contact Stryker Instruments for further instructions on how to proceed.
The recalled product
- Product
- 5.0mm 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)
- 5190-010-050 5.0mm Round Fluted Bur
- Super Long
- Lot Number: 15322017
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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