The Recall Desk
ModerateFDA (Devices)·Z-1569-2022·Announced 2022-08-31

Anatomical Model Recalled for Wrong Product Shipped in Packaging

Materialise USA LLC is recalling ProPlan CMF Anatomical Model units where packages labeled MU22-INA-DUQ contained the wrong anatomical model inside. Recipients should verify their package contents match the label.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall stems from a labeling and product shipment error with no reported illnesses, injuries, or deaths. While such errors could disrupt workflows, the absence of reported harm classifies this as Moderate severity.

Plain-English summary

Materialise USA LLC is recalling certain ProPlan CMF Anatomical Model units (Identification number SD900.208, lot MU22-INQ-DUQ). Packages labeled with model designation MU22-INA-DUQ were shipped containing a different anatomical model—the model from case MU22-NOF-SAK—instead of the labeled product.

This packaging and labeling mismatch could prevent proper product identification and disrupt workflows that depend on receiving the correct anatomical model for surgical planning or other medical procedures.

Recipients should immediately verify that the contents of their packages match the label. If the contents do not match the label, contact Materialise USA LLC.

The recalled product

Product
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Manufacturer
Materialise USA LLC
Hazard
  • product-mismatch
  • labeling-error

Distribution

Distributed nationwide across the United States.