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Recall Observatory FDA recall evidence

Device product

DeRoyal TOTAL HIP KIT, REF 89-9498.08

Z-0657-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
51 kits
Official record key
device-enforcement:Z-0657-2023

Official wording

Reason: XXX

Code information: Lot Numbers: Lot 56187960 exp 12/4/2024; Lot 57031051 exp 3/1/2025

Distribution pattern: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    XXX