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Recall Observatory FDA recall evidence

Device product

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

Z-0976-2024

December 21, 2023

Class II

Product summary

Firm
G & H Wire Company
Event
Event 93810
Status
Ongoing
Classification
Class II
Quantity
81 pk (100/pk)
Official record key
device-enforcement:Z-0976-2024

Official wording

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

Code information: UDI: 10195291042642 Lot Number: 1120035

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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