Band, Elastic, Orthodontic

FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap,

Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy

Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELA

On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". The firm's HHE identified this as a potential high health risk to the patients or end users with latex allergies.

Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into

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.