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Recall Observatory FDA recall evidence

Device product

Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

Z-0378-2014

October 10, 2013

Class II

Product summary

Firm
Mizuho America, Inc.
Event
Event 66561
Status
Terminated
Classification
Class II
Quantity
35
Official record key
device-enforcement:Z-0378-2014

Official wording

Reason: Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

Code information: Product Code 17-001-58; Lot No. 29JY

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.