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Recall Observatory FDA recall evidence

Device product

Stryker 5.0mm Barrel Bur Sterile

Z-1768-2014

May 22, 2014

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 68331
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-1768-2014

Official wording

Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Code information: Part Number 5820-17-50, Lot Number 13345017

Distribution pattern: Worldwide Distribution - US (nationwide)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.