Materialise N.V. recalls ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgic…
- Recall date
- June 19, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2287-2023
- FDA classification
- Class II
- Brand / firm
- Materialise N.V.
- Sold / distributed
- US Nationwide distribution in the state of KY.
Why it was recalled
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
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