medical Class II Updated 2023-08-09

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

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
View official government recall

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