FDA recall Z-1569-2022

Materialise USA LLC · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the state of MD.

Key facts

Status
Completed
Initiation date
2022-07-13
Report date
2022-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plymouth, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1569-2022