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Recall Observatory FDA recall evidence

Device product

5.0mm Round Fluted Bur, Super Long

Z-2204-2016

June 16, 2016

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 74562
Status
Terminated
Classification
Class II
Quantity
25
Official record key
device-enforcement:Z-2204-2016

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: 5190-010-050  5.0mm Round Fluted Bur, Super Long , Lot Number: 15322017

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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign body