FDA Recalls 3D Systems VSP Scapula Marking Guide Due to Design Defect
Medical Modeling, Inc. is recalling the 3D Systems VSP Reconstruction Scapula Marking Guide (Model VSPR-301) because it was incorrectly designed. The device was distributed internationally, including to Germany.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product—a surgical device with a documented design defect—where no injuries or illnesses have been reported in the source material. Although it is a Class II recall affecting surgical equipment function, the absence of reported harm limits the severity classification to High.
Plain-English summary
Medical Modeling, Inc. is recalling the 3D Systems VSP Reconstruction Scapula Marking Guide, Model VSPR-301. This non-sterile, prescription medical device is used as a surgical marking and positioning guide in shoulder procedures. The affected lot is #167559 (UDI: 00816847020886).
The device was recalled because it was incorrectly designed, which could affect its proper function in surgical applications.
The recalled device was distributed internationally, including to Germany. Patients and healthcare providers who have received this device should consult with their healthcare provider regarding any necessary steps.
The recalled product
- Product
- 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
- Manufacturer
- Medical Modeling, Inc.
- Hazard
- 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)
- Lot # 167559
- UDI: (01) 00816847020886
Distribution
Distribution scope not specified by the agency.
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