FDA recall Z-0976-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2023-12-21

Report date

2024-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0976-2024