Device product
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Z-0976-2024
Product summary
- 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
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy