ProPlan CMF recallZ-1569-2022 · Materialise USA LLC · initiated Jul 13, 2022
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Materialise USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1569-2022
- Status
- Completed
- Initiated by the company
- Jul 13, 2022
- Recalling firm
- Materialise USA LLC
- Quantity
- 1 unit
- Product code
- HWT
- Distribution
- US Nationwide distribution in the state of MD.
Product description
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Code information (models, lots, serial numbers)
Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ProPlan CMF SD900.208Materialise NV · Template1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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