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Summary
The FDA issued a Class II for CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dim by Trophy SAS. Reason: Device failed to function as intended and/or failed to conform to their design specifications..
Details
Source
Device Recall
External ID
Z-1627-2023
Action Date
2023-06-07
Status
Ongoing
Category
device
Product Description
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Lot/Code Info: CS 9600
Quantity Affected: 895 units
Reason for Recall
Device failed to function as intended and/or failed to conform to their design specifications.
Distribution
Worldwide Distribution
Type: FDA Mandated
Recall Initiated: 2021-07-21
Company
Marne La Vallee Cedex 2, N/A
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 137 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 (Trophy SAS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trophy SAS have FDA actions?
This is the only FDA action we have on record for Trophy SAS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1627-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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