Z-0976-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- December 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 pk (100/pk)
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
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.
Code Information
UDI: 10195291042642 Lot Number: 1120035