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Recall Observatory FDA recall evidence

Device product

DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02

Z-0706-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
117 kits
Official record key
device-enforcement:Z-0706-2023

Official wording

Reason: XXX

Code information: Lot Numbers: 56296761 exp 10/01/2023; 56717318 exp 11/01/2023; 57136671 exp 11/01/2023; 57225673 exp 11/01/2023; 57225817 exp 02-01-2024; 57455920 exp 02-01-2024; 57646161 exp 02-01-2024; 57889699 exp 02-01-2024; 58003853 exp 02-01-2024

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