FDAFDA · Food and drugs·Recall number Z-1510-2022
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Published August 17, 2022 · Recall initiated: May 17, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medical Modeling, Inc.
- Distributor
- International distribution in the country of Germany.
- Lot
- Lot # 167559; UDI: (01) 00816847020886
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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