Date Initiated by Firm | May 23, 2022 |
Create Date | August 02, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1494-2022 |
Recall Event ID |
90639 |
Product Classification |
Device, anti-snoring - Product Code LRK
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Product | CustMbite, Model Number CBT-SRS-UL |
Code Information |
UDI-DI: N/a
Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222 |
Recalling Firm/ Manufacturer |
Dental Choice Holding Llc 10100 Linn Station Rd Louisville KY 40223-3861
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For Additional Information Contact | Dental Choice Holdings Customer Service 855-253-4680 |
Manufacturer Reason for Recall | The device was marketed and sold in the US without FDA clearance. |
FDA Determined Cause 2 | No Marketing Application |
Action | Firm began notifying customers via recall letters on 5/23/22 and 6/6/22. A second round of letters was sent on 6/30/22 non-responding customers.
Customers are instructed to cease use of the product and to discard it immediately. The firm will provide a full refund to affected customers.
To receive a full refund of the purchase price, please contact Dental Choice Holdings Customer Service between the hours of 9am and 5pm Eastern Standard Time at 1-(855)-253-4680 or send an email to customerservice@custmbite.com. |
Quantity in Commerce | 708 |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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