FDAFDA · Food and drugs·Recall number Z-2205-2016
6.0mm Round Fluted Bur, Super Long
Published July 20, 2016 · Recall initiated: June 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands
- Lot
- 5190-010-060 Lot Numbers 15231017, 16033017, 16066017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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