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Open, Classified

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

FDA Recall Z-1510-2022 · Posted None

Recalling FirmMedical Modeling, Inc.
Recall StatusOpen, Classified
Product CodeDZJ
Date Initiated2022-05-17
Product Quantity1 unit

Reason for Recall

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

Firm 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.

Root Cause

Employee error

Distribution Pattern

International distribution in the country of Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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