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Recall Observatory FDA recall evidence

Device product

Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

Z-1921-2023

May 03, 2023

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 92359
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1921-2023

Official wording

Reason: The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.

Code information: UDI-DI: 07613327188660; Lot Number: G7207242

Distribution pattern: International distribution in the country of Ireland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.