Recall Z-1164-2021— G & H Wire Company
Class II · Terminated
Class II FDA medical device recall by G & H Wire Company, initiated 2021-01-21, terminated 2021-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- G & H Wire Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-21
- Terminated
- 2021-09-20
- Firm location
- Franklin, IN, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.