Recall Z-0976-2024— G & H Wire Company
Class II · Ongoing
Class II FDA medical device recall by G & H Wire Company, initiated 2023-12-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- G & H Wire Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-21
- Firm location
- Franklin, IN, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.