Class II

Medical Device Recall: FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

G & H Wire Company · December 21, 2023

Reason for Recall

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

Distribution

Worldwide - US Nationwide distribution in the states of UT, MO, WV, TX, NJ and the countries of Canada, France, Germany, New Zealand, South Africa, Thailand.

States Affected

NATIONWIDE

Quantity Affected

81 pk (100/pk)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0976-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

G & H Wire Company Medical Device Recall: FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56 | SafeCheck