Stryker Instruments Div. of Stryker Corporation recalls 6.0mm Round Fluted Bur, Super Long

Recall date

June 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2205-2016

FDA classification

Class II

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

6.0mm Round Fluted Bur, Super Long