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Recall Observatory FDA recall evidence

Device product

Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S

Z-2171-2021

May 27, 2021

Class II

Product summary

Firm
Stryker GmbH
Event
Event 88240
Status
Ongoing
Classification
Class II
Quantity
242
Official record key
device-enforcement:Z-2171-2021

Official wording

Reason: The devices have a different inner diameter than the diameter specified on the outer box label.

Code information: GTIN 04546540715357, Lot Number K03CC4F

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The devices have a different inner diameter than the diameter specified on the outer box label.