FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
FDA Recall #Z-0976-2024 — Class II — December 21, 2023
Product Description
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
Recalling Firm
G & H Wire Company — Franklin, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
81 pk (100/pk)
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.
Code Information
UDI: 10195291042642 Lot Number: 1120035
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated