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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 1
Distribution
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