Device product
6.0mm Round Fluted Bur, Super Long
Z-2205-2016
Product summary
- Event
- Event 74562
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-2205-2016
Official wording
Reason: 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.
Code information: 5190-010-060 Lot Numbers 15231017, 16033017, 16066017
Distribution pattern: US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands
Derived failure modes
-
Foreign material or chemical contamination
foreign body