Band — Class II medical device recall Z-1164-2021
Terminated recall by G & H Wire Company, reported 2021-03-10, distributed nationwide. The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect d
| Recall number | Z-1164-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | G & H Wire Company, Franklin, IN, United States |
| Recall initiated | 2021-01-21 |
| Classified | 2021-03-03 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2021-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CZ, DE, DK, ES, FR, GB, GR, NL, NZ, PL, TH |
| Reason classes | labeling, device malfunction |
| Lot numbers | 802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158 |
| Model numbers | AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1164-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.