Z-1510-2022Class II

3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only...

Name: Z-1510-2022 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only...
Creator: Medical Modeling, Inc.
Published: 2022-05-17
License: https://open.fda.gov/license/

Medical Modeling - a 3D Systems Company / initiated 2022-05-17 / Open, Classified / root cause: manufacturing process

FDA source

Medical Modeling, Inc. began a recall of 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile on 2022-05-17. FDA classified it as Class II and gives the reason as "Scapula Marking Guide (anatomically Shaped) was incorrectly designed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1510-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-17
Posted: 2022-08-09
Recalling firm: Medical Modeling - a 3D Systems Company
Product: 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Product code: DZJ Driver, Wire, And Bone Drill, Manual
Reason for recall: Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 unit
Distribution: International distribution in the country of Germany.
Product codes and lots: Lot # 167559; UDI: (01) 00816847020886

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1510-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1510-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-09

Product code DZJ

K133907Class IIVsp SystemMedical Modeling, Inc. / cleared 2014-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)