Recall Z-1569-2022
Materialise USA LLC · initiated July 13, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Codes / lots: Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ
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
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-1569-2022
- Initiated
- July 13, 2022
- Product code
- HWT – Template
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of MD.
- Recalling firm
- Materialise USA LLC, Plymouth, MI