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Recall Observatory FDA recall evidence

Device product

DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01

Z-0692-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
1196 kits
Official record key
device-enforcement:Z-0692-2023

Official wording

Reason: XXX

Code information: Lot Numbers: Lot 56190288 exp 8/1/2023; Lot 56224943 exp 8/1/2023; Lot 56432718 exp 2/1/2023; Lot 56432726 exp 8/1/2023; Lot 56639065 exp 8/1/2023; Lot 56906961 exp 8/1/2023; Lot 57051271 exp 8/1/2023; Lot 57228161 exp 8/1/2023; Lot 57393491 exp 1/1/2024; Lot 57488967 exp 3/1/2024; Lot 57679350 exp 3/1/2024; Lot 57685371 exp 3/1/2024; Lot 57751551 exp 3/1/2024

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