G & H Wire Company recalls Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy…

Recall date

January 21, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1164-2021

FDA classification

Class II

Brand / firm

G & H Wire Company

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.