Materialise N.V ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to recall — FDA Z-2287-2023
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Overview of recall records associated with Materialise N.V., including dates, categories and classifications where available.
Classification mix: Class II: 2.
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
The wrong tibia guide was included intended for a different patient case.
This page summarizes recall records in which the official source identifies Materialise N.V. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.