3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Steril
Summary
The FDA issued a Class II for 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (A by Medical Modeling, Inc.. Reason: Scapula Marking Guide (anatomically Shaped) was incorrectly designed..
Details
Source
Device Recall
External ID
Z-1510-2022
Action Date
2022-08-17
Status
Ongoing
Category
device
Product Description
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Lot/Code Info: Lot # 167559; UDI: (01) 00816847020886
Quantity Affected: 1 unit
Reason for Recall
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Distribution
International distribution in the country of Germany.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-17
Company
Littleton, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 96 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medical Modeling, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medical Modeling, Inc. have FDA actions?
This is the only FDA action we have on record for Medical Modeling, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1510-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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