The Recall Desk
HighFDA (Devices)·Z-1510-2022·Announced 2022-08-17

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.

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 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.
Category
Medical Device — Surgical Instruments
Hazard
  • design-defect

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.

Related recalls

Same category