G & H Wire Recalls
2 recalls on record · March 10, 2021 to February 14, 2024 · Medical Devices
Recalls by year
21
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 14, 2024Medical DevicesFDA
G & H Wire Company recalls FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Hazard: Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
March 10, 2021Medical DevicesFDA
G & H Wire Company recalls Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy l
Hazard: 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.