Materialise recalls ProPlan CMF Patient-Specific Mandible Guides 3A and : Wrong versions shipped before redesign request. Check identification number SD900.101 or UDI 05420060351013.
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Materialise is recalling ProPlan CMF Patient-Specific Mandible Guides 3A and 3B because wrong versions were shipped before the redesign request. This could lead to incorrect surgical guidance if used without verification.
The guides were shipped before the redesign request, meaning they might not match the intended surgical markings. Using incorrect guides could lead to improper bone marking during surgery.
Orthodontists and maxillofacial surgeons who use these guides for surgical procedures. Patients undergoing jaw surgery are at risk if the wrong guides are used.
Check for identification number SD900.101 or unique device identifier (UDI) 05420060351013 on the product packaging. These guides were sold with lot case number MU23-JOQ-LID.
Look for identification number SD900.101 or UDI 05420060351013 on the product packaging.
Wrong versions of guides 3A and 3B were shipped before the redesign request.
Check for identification number SD900.101 or UDI 05420060351013 on the product packaging.
The recall record does not specify a remedy, so contact Materialise directly for guidance.
We’ve drafted a message you can send Materialise to request your refund or repair — edit it as you like.
Subject: Recall Z-2287-2023 — Materialise Materialise Hello, I own a Materialise that is covered by recall Z-2287-2023 from Materialise. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
