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Recall Observatory FDA recall evidence

Device product

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

Z-1569-2022

July 13, 2022

Class II

Product summary

Firm
Materialise USA LLC
Event
Event 90704
Status
Completed
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1569-2022

Official wording

Reason: MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

Code information: Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ

Distribution pattern: US Nationwide distribution in the state of MD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK