VSP System recallZ-1510-2022 · Medical Modeling, Inc. · initiated May 17, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Modeling, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1510-2022
- Status
- Open, Classified
- Initiated by the company
- May 17, 2022
- Recalling firm
- Medical Modeling, Inc.
- Quantity
- 1 unit
- Product code
- DZJ
- FDA submissions
- K133907
- Distribution
- International distribution in the country of Germany.
Product description
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Code information (models, lots, serial numbers)
Lot # 167559; UDI: (01) 00816847020886
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VSP System Scapula Marking Guide3d Systems, Inc. · System, Image Processing, Radiological1 recall0 reports
Product lines
Other devices under the same FDA submission
13 devices cleared under K133907 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- VSP System Mandible Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual13 reports
- VSP System Mandible Marking Guide3d Systems, Inc. · System, Image Processing, Radiological7 reports
- VSP System Intermediate Surgical Splint3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Final Surgical Splint3d Systems, Inc. · System, Image Processing, Radiological6 reports
- VSP System Fibula Cutting Guide with Implant Placement3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Fibula Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual5 reports
- VSP System Maxilla Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual4 reports
- VSP System LeFort Marking Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual3 reports
- VSP System Surgical Splint3d Systems, Inc. · System, Image Processing, Radiological2 reports
- VSP System Sagittal Split Marking Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual1 report
- VSP System Genioplasty Drilling Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual1 report
- VSP System Genioplasty Marking Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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