ProPlan CMF Mandible Surgical Guides Recall for Wrong Version
Materialise recalls ProPlan CMF mandible surgical guides because wrong versions were shipped prior to a redesign. Healthcare facilities should verify they have the correct version.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a surgical device where the incorrect version was shipped. While no illnesses or injuries have been reported, using wrong surgical guides during mandibular procedures presents direct risk of surgical error and complications. This meets the High severity threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Materialise N.V. is recalling ProPlan CMF Patient-Specific Guides (mandible guides 3A and 3B), which are intended to guide bone marking and surgical instruments during mandibular and maxillofacial surgical procedures.
The recall was issued because wrong versions of guides 3A and 3B were shipped prior to a redesign request. Using incorrect guides in surgical procedures could result in improper surgical guidance and potential surgical complications.
This recall affects healthcare facilities nationwide that received the affected guides (UDI: 05420060351013, Lot Case Number: MU23-JOQ-LID). Healthcare providers should verify they have the correct version and contact Materialise with any questions or concerns.
The recalled product
- 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
- Materialise N.V.
- Category
- Medical Device — Surgical Guide
- Hazard
- surgical-error-risk
- device-version-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
Distribution
Distributed nationwide across the United States.
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