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Materialise N.V. FDA Recalls
2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgicaClass IIJun 19, 2023Wrong versions of guides 3A and 3B (Patient Specific) were s |
| MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched devClass IIApr 26, 2023The wrong tibia guide was included intended for a different |