ProPlan CMF Anatomical Model (Materialise) – Incorrect Shipping (2022)
Incorrect anatomical model labeling may cause administrative confusion.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Brand
Materialise USA LLC
Lot Codes / Batch Numbers
Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ
Products Sold
Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ
Materialise USA LLC is recalling ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208 due to MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
Recommended Action
Per FDA guidance
Materialise USA LLC notified field representative via telephone on 13 July 2022 requesting the case to be returned. A replacement case was sent on 14 July 2022. Materialise picked up/received MU22-INQ-DUQ case with anatomical model MU22-NOF-SAK on 22 July 2022. This recall can be terminated as all distributed product (one case) has been returned to Materialise. No additional product remains in the field.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026