Medical device recalls Moderate risk

3D Systems VSP Reconstruction recalled over sterility concerns

Recall date
May 17, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Medical Modeling, Inc. recalls 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Steri…
Recall number
Z-1510-2022
FDA classification
Class II
Brand / firm
Medical Modeling, Inc.
Sold / distributed
International distribution in the country of Germany.

Why it was recalled

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever Medical Modeling, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Medical Modeling, Inc.