Recall archive / FDA device enforcement
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Ste... — FDA record Z-1510-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 17, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
- Reason
- Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
- Classification
- Class II
- Recalling firm
- Medical Modeling, Inc.
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1510-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 167559; UDI: (01) 00816847020886 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of Germany.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 17, 2022
- Recall initiation date
- May 17, 2022
- Center classification date
- Aug 9, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.