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Completed

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

FDA Recall Z-1569-2022 · Posted None

Recalling FirmMaterialise USA LLC
Recall StatusCompleted
Product CodeHWT
Date Initiated2022-07-13
Product Quantity1 unit

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution in the state of MD.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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