Recall Z-1164-2021 ยท ECI Band, Elastic, Orthodontic
G & H Wire Company
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.
| Date | Jan 21, 2021 |
| Status | Terminated |
| Reason | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort. |
| Root cause | Process control |
| Action | On 1/21/2021, G&H Orthodontics issued a Product Recall Notice to customers via email notifying affected users of a voluntary recall for FlexMedics Patient Elastic Packs. A labelling change that resulted in the color scheme of the FlexMedics Patient Packs product to be updated which was not intended and could result in consumer confusion and/or patient discomfort. |
| Quantity | 371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, CT, FL, IL, KY, MI, MN, MS, MT, NH, NJ, NY, NC, TN, TX, UT, VT, WA, WV, AR, IL, and the countries of Spain, Netherlands, New Zealand, Germany, France, Czech Republic, Greece, Poland, Thailand, Belgium, Denmark, United Kingdom, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.