FDAClass IIAugust 17, 2022

3D Systems VSP Reconstruction recall

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

Why was 3D Systems VSP Reconstruction recalled?

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 167559; UDI: (01) 00816847020886

Product
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Recalling firm
Medical Modeling, Inc.
Quantity
1 unit
Distribution
International distribution in the country of Germany.
Recall date
August 17, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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