Medical device recalls Moderate risk

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

Recall date
December 21, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0976-2024
FDA classification
Class II
Brand / firm
G & H Wire Company
Sold / distributed
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.

Why it was recalled

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

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

What was recalled

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

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