FDA Device recall Z-1510-2022
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
- FDA Device
- Class II
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class II recall of 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile by Medical Modeling, citing scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1510-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-17 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medical Modeling |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot # 167559; UDI: (01) 00816847020886 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1510-2022%22
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