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Recall Observatory FDA recall evidence

Device product

DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11

Z-0659-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
360 kits
Official record key
device-enforcement:Z-0659-2023

Official wording

Reason: XXX

Code information: Lot Numbers: Lot 56388673 exp 6/1/2026; Lot 56842522 exp 6/1/2026; Lot 57271485 exp 9/1/2026; Lot 57512154 exp 11/1/2026

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