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U.S. Department of Health and Human Services

Class 2 Device Recall KeyPrint KeySplint Soft

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  Class 2 Device Recall KeyPrint KeySplint Soft see related information
Date Initiated by Firm June 25, 2021
Create Date August 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-2336-2021
Recall Event ID 88427
510(K)Number K183598  
Product Classification Mouthguard, prescription - Product Code MQC
Product KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

Model (Ref) #: 4220005
Code Information Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact SAME
978-747-2560
Manufacturer Reason
for Recall		 Product label intended for the European community was distributed to the USA market via their US distribution organization
FDA Determined
Cause 2		 Process control
Action Straumann USA initial notification to the customer via phone call on 25 June 2021. A follow-up letter dated 7/2/21 issued. Letter states reason for recall, health risk and action to take: Action to be taken: 1. Based on our conversation on 25 June 2021, you did not use and you have segregated the product and it was made ready to ship back to us. 2. Complete and return the enclosed Customer Confirmation Form to FSCA ER21-0118, Straumann USA, LLC; 60 Minuteman Road, Andover, MA 01810 along with the product using the attached label.
Distribution US Nationwide distribution in the state of TX.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = MQC and Original Applicant = Keystone Industries
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