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Materialise USA LLC recalls ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Inte
Recalled January 1, 2014 · FDA recall Z-0577-2014 · Materialise USA
Hazard
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. · FDA Class II
Units
1
Sold at
Distributed in Canada.
Description
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Product
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
Manufacturer(s)
Materialise USA LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →