Recall Z-1569-2022 ยท HWT Template
Materialise USA LLC
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
| Date | Jul 13, 2022 |
| Status | Completed |
| Reason | MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK |
| 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 | 1 unit |
| Distribution | US Nationwide distribution in the state of MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.