Materialise N.V. recalls ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B
Recalled Product
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
Hazard / Issue
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Issued by
FDA
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