Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports
Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.
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: The recall involves a risk-of-harm product (surgical guide) where using the incorrect patient-specific plan could lead to surgical errors, but no injuries or illnesses are reported in the source text.
Plain-English summary
Materialise USA LLC is recalling patient-specific orthognathic surgical guides, specifically the ProPlan CMF Guide Model REF SD900.008. These single-use, prescription-only devices are used as surgical tools to transfer a pre-operative plan to surgery.
The recall was initiated because the patient-specific guides contained the incorrect case report. Since the case report contains patient-specific surgical plan information, using the incorrect report could result in the wrong surgical plan being applied during the procedure.
The source text indicates that these products were distributed in Canada. No specific dates, lot numbers, or unit counts are provided in the source text. Healthcare providers and patients should verify the specific case report associated with their surgical guides to ensure the correct patient-specific plan is being used.
The recalled product
- Product
- 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. .
- Manufacturer
- Materialise USA LLC
- Category
- Medical Device — Surgical Guides
- Affected units
- 1
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 (2)
- Item reference SD900.106
- Unique Instrument ID MC13-OVA-OGO_2
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Materialise USA LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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