Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ProPlan CMF Patient-Specific Guide Recalled by Materialise N.V. Due to Wrong versions of guides 3A and 3B (Patient...
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 N.V. directly.
Affected Products
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
Quantity: 1 unit
Why Was This Recalled?
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Materialise N.V.
Materialise N.V. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report