Reported Aug 17, 2022 · Ongoing

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

Medical Modeling, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medical Modeling, Inc. · 5381 S Alkire Cir · Littleton, CO · 80127-1403

Is this the product you have?

  • 3D Systems VSP Reconstruction
  • ModelVSPR-301
  • ProductScapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Lot codes and dates
  • Lot # 167559
  • UDI(01) 00816847020886
Amount recalled
1 unit

Why it was recalled

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

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