FDA Medical Device Recalls (openFDA)
Medical Modeling, Inc.: 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
- Recall number
- Z-1510-2022
- Recalling firm
- Medical Modeling, Inc.
- Product
- 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
- Status
- Open, Classified
- Initiated
- 2022-05-17
- Posted
- not on file
- Terminated
- not on file
- Reason
- Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 1 unit
- Distribution
- International distribution in the country of Germany.
- Lot, serial or model codes
- Lot # 167559; UDI: (01) 00816847020886
- 510(k) numbers
- ["K133907"]
- PMA numbers
- not on file
- Product code
- DZJ
- Firm FEI
- 3003142829
- Firm city
- Littleton
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28