FDA-Device2016-07-20Class II

6.0mm Round Fluted Bur, Super Long

Stryker Instruments Div. of Stryker Corporation
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.

Sold states
US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands
Affected count
25
Manufactured in
4100 E Milham Ave, Portage, MI, United States
Products
6.0mm Round Fluted Bur, Super Long

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2205-2016

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