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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXSelect Elastic Bands

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  Class 2 Device Recall FLEXSelect Elastic Bands see related information
Date Initiated by Firm December 21, 2023
Date Posted February 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-0976-2024
Recall Event ID 93810
Product Classification Band, elastic, orthodontic - Product Code ECI
Product FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap,
Ref: AMD56
Code Information UDI: 10195291042642 Lot Number: 1120035
Recalling Firm/
Manufacturer		 G & H Wire Company
2165 Earlywood Dr
Franklin IN 46131-8879
For Additional Information Contact SAME
317-346-6655
Manufacturer Reason
for Recall		 Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
FDA Determined
Cause 2		 Packaging process control
Action G&H Orthodontics issued Product Recall Notice to customers on 12/21/23 via E-mail and phone call. Letter states reason for recall, health risk and action to take: Required Action for Users: Return product for disposal. Follow-up Actions by G&H: Flexmedics intends to replace products with accurately labeled products. You may reach G&H at 1.800.526.1026 or 1.31 7.346.6655 if you have additional questions. We are open 7 AM - 7PM US Eastern Time weekdays
Quantity in Commerce 81 pk (100/pk)
Distribution Worldwide - US Nationwide distribution in the states of UT, MO, WV, TX, NJ and the countries of Canada, France, Germany, New Zealand, South Africa, Thailand.
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.
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