Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only Recalled by Materialise USA LLC Due to Patient Specific Guide contained the incorrect case report....
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Materialise USA LLC directly.
Affected Products
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
Quantity: 1
Why Was This Recalled?
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Where Was This Sold?
Distributed in Canada.
About Materialise USA LLC
Materialise USA LLC has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report