Reported Aug 31, 2022 · Completed
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Materialise USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Materialise USA LLC · 44650 Helm Ct · Plymouth, MI · 48170-6061
Is this the product you have?
- ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
- Lot codes and dates
- Unique Device Identifier (01)05420060352089(10)MU22INADUQ
- Lot NumberMU22-INQ-DUQ
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- MD
Why it was recalled
MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
This product could cause temporary or reversible health problems — stop using it.
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