Recall Z-0976-2024 ยท ECI Band, Elastic, Orthodontic
G & H Wire Company
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
| Date | Feb 2, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| Reason | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.