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U.S. Department of Health and Human Services

Class 2 Device Recall Terragene Integron/Benco/Tutnauer

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  Class 2 Device Recall Terragene Integron/Benco/Tutnauer see related information
Date Initiated by Firm December 07, 2023
Date Posted January 26, 2024
Recall Status1 Open3, Classified
Recall Number Z-0836-2024
Recall Event ID 93625
510(K)Number K191021  
Product Classification Indicator, physical/chemical sterilization process - Product Code JOJ
Product Terragene Integron IT26-C

Terragene Integron IT26-C with extender

Benco Dental Chemical Integrator [5726-583]

Tuttnauer (WTL198-0082)

Terragene Integron (PCD26-C)

Terragene Bionova PCD (PCD222-C)
Code Information Product Number: IT26-C UDI-DI code: 07798164679622 Lot Numbers: 19033 19038 19039 19040 19057 19105-12 19105-16 B10400-13 B10400-14 B10400-16 B10400-21 B10400-23 19105-23 19105-24 B10519 B10555 B10625 B10627 B10628 B10629 B20040 B20043 B30012 B30013 B30110 B30111 B30112 Product Number: IT26-C with extender UDI-DI code: 07798164678656 Lot Numbers: 19059 B10572 B30068 B30110 Product Number: Terragene Integron (PCD26-C) UDI-DI code: 07798164679370 Lot Numbers: 100320 110320 220620 F10009 F20026 F20079 F20084 Product Number: Benco Dental Chemical Integrator 5726-583 UDI-DI code: 00366975058768 Lot Numbers: 131120-8 131120-1 131120-2 131120-4 131120-7 131120-5 131120-11 131120-3 131120-16 131120-15 131120-12 131120-19 131120-10 131120-6 131120-18 131120-17 131120-14 131120-13 131120-9 B10540 B20039 B20185 B20576 B30010 B30138 Product Number: Tuttnauer (WTL198-0082) UDI-DI code: 07798164677888 Lot Numbers: 120320 170920-3 170920-2 170920-1 170920-8 170920-7 170920-6 170920-5 170920-4 B10331-1 B10331-2 B10331-3 B10539 B20679
Recalling Firm/
Manufacturer		 TERRAGENE S.A.
Ruta Nacional N 9, Km 280, Cp 2130
Parque Industrial Micropi
Alvear Argentina
For Additional Information Contact Customer Service
844-8377243
Manufacturer Reason
for Recall		 Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
FDA Determined
Cause 2		 Labeling False and Misleading
Action On 12/07/2023, the firm notified via email its initial importers/distributor a "Voluntary Recall Notification " that contained a "COMMUNICATION TO CUSTOMER VOLUNTARY RECALL OF PRODUCT/URGENT: MEDICAL DEVICE RECALL" Letter informing them of the discrepancies identified in the IFUs of some products that mentions extended cycles that may mislead users to think that these cycles are part of the FDA-cleared indications for use of the product. Initial Importers/Distributors are instructed to send the following information to Terragene: -Quantity in stock -Quantity distributed -Consignees On or about 12/22/2023, the firm initiated distribution, via email, an "URGENT: MEDICAL DEVICE RECALL" Letter to customers (identified by their Initial Imports/Distributors) informing them of the Recall issue (discrepancy identified in the IFU) provide an updated IFU (version 4) correcting the issue. Customers are instructed to print the updated IFU and attach it to their remaining inventory, and to discard the older IFU versions (version 1 thru 3). For questions or concerns, contact customer.service@terragene.com or www.terragene.com , or +1-844-837-7243 Monday thru Friday 6:00 AM to 3:00 PM, Eastern Time.
Quantity in Commerce 36,857 strips
Distribution U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
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 = JOJ and Original Applicant = Terragene SA
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