6.0mm Round Fluted Bur recall: Foreign Material
6.0mm Round Fluted Bur, Super Long
Why was 6.0mm Round Fluted Bur recalled?
Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
5190-010-060 Lot Numbers 15231017, 16033017, 16066017
- Product
- 6.0mm Round Fluted Bur, Super Long
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 25
- Distribution
- US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands
- Recall date
- July 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)