Z-1569-2022Class II

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

Name: Z-1569-2022 ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Creator: Materialise USA LLC
Published: 2022-07-13
License: https://open.fda.gov/license/

Materialise USA, LLC. / initiated 2022-07-13 / Completed / root cause: manufacturing process

FDA source

Materialise USA LLC began a recall of ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208 on 2022-07-13. FDA classified it as Class II and gives the reason as "MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1569-2022
Classification: Class II
Status: Completed
Initiated: 2022-07-13
Posted: 2022-08-24
Recalling firm: Materialise USA, LLC.
Product: ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Product code: HWT Template
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
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of MD.
Product codes and lots: Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1569-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1569-2022	Class II	Completed	Voluntary: Firm initiated	2022-08-31	2022-08-24

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)