FDAJune 16, 2016device
6.0mm Round Fluted Bur, Super Long
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
stryker instruments divstrykerstryker instruments
Recall history
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- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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