# FDA recall Z-1164-2021

> **G & H Wire Company** · Class II · device recall initiated 2021-01-21.

## 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.

## 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, Canada.

## Key facts

- **Recall number:** Z-1164-2021
- **Recalling firm:** G & H Wire Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-21
- **Report date:** 2021-03-10
- **Termination date:** 2021-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franklin, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1164-2021

## Citation

> AI Analytics. FDA recall Z-1164-2021. Retrieved 2026-08-21 from https://api.ai-analytics.org/recall/Z-1164-2021. Source: US FDA. Licensed CC0.

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