Recall Z-1510-2022— Medical Modeling, Inc.

Name: FDA recall Z-1510-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-17

Class II · Ongoing

Class II FDA medical device recall by Medical Modeling, Inc., initiated 2022-05-17. It names one FDA 510(k) clearance: K133907. 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..

Recalling firm: Medical Modeling, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-05-17
Firm location: Littleton, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K133907 — VSP SYSTEMMedical Modeling, Inc.·cleared 2014-01-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.