FDA Device recall Z-1164-2021
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that…
- FDA Device
- Class II
- terminated
- Published 2021-03-10
On 2021-03-10 the FDA classified a Class II recall of Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that… by G And H Wire, citing 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 de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1164-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-21 |
| Published | 2021-03-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | G And H Wire |
| Distribution | US |
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.
Identifiers
| code_info | Part Number: AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36. Lot Number: 802028, 811671, 811672, 811673,…Part Number: AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36. Lot Number: 802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1164-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.