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 high-risk surgical device where the incorrect patient-specific plan could lead to significant harm, but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Materialise USA LLC is recalling the ProPlan CMF Patient-Specific Orthognathic Intermediate Surgical Guides (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. The case report contains patient-specific surgical plan information, meaning the guides may not correspond to the correct patient's surgical plan.
The affected units were distributed in Canada. The source text does not specify the number of units recalled or report any injuries or illnesses associated with the use of these devices.
The recalled product
- Product
- ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate 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_01
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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