VSP Reconstruction (Medical Modeling) – Design Issue (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Brand
Medical Modeling, Inc.
Lot Codes / Batch Numbers
Lot # 167559, UDI: (01) 00816847020886
Products Sold
Lot # 167559; UDI: (01) 00816847020886
Medical Modeling, Inc. is recalling 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), due to Scapula Marking Guide (anatomically Shaped) was incorrectly designed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Recommended Action
Per FDA guidance
On May 17, 2022, Medical Modeling - A 3D systems Company representative contacted affected customer via phone and informed the consignee of the issue and their plan to remove the device and provide a new one.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026