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Materialise N.V. recalls ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgica
Recalled August 9, 2023 · FDA recall Z-2287-2023 · Materialise N.V
Hazard
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of KY.
Description
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
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
Manufacturer(s)
Materialise N.V.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →