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Recall Observatory FDA recall evidence

Device product

This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225

Z-2261-2024

June 03, 2024

Class II

Product summary

Firm
Stryker Corporation
Event
Event 94755
Status
Ongoing
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-2261-2024

Official wording

Reason: Expired Products distributed to customers

Code information: GTIN: 07613327118438 Lot Number: 1000388946

Distribution pattern: US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Expired Products distributed to customers