FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
This recall is currently active, issued February 2, 2024. It was issued by G & H Wire Company.
- Company
- G & H Wire Company
- Recall Initiated
- December 21, 2023
- Posted
- February 2, 2024
- Recall Number
- Z-0976-2024
- Quantity
- 81 pk (100/pk)
- Firm Location
- Franklin, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
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.
Lot / Code Info
UDI: 10195291042642 Lot Number: 1120035
Root Cause
Packaging process control
Action Taken
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