FDA Enforcement
Class II
Ongoing
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Recall: Z-0976-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0976-2024
- Event ID
- 93810
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- G & H Wire Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- February 14, 2024
- Initiation Date
- December 21, 2023
- Classification Date
- February 2, 2024
- Address
- 2165 Earlywood Dr, Franklin, IN, 46131-8879, United States
Description
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Reason
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
Code Info
UDI: 10195291042642 Lot Number: 1120035
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.
Quantity
81 pk (100/pk)