Z-0976-2024Class II

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

Name: Z-0976-2024 FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Creator: G & H Wire Company
Published: 2023-12-21
License: https://open.fda.gov/license/

G & H Wire Company / initiated 2023-12-21 / Open, Classified / root cause: packaging

FDA source

G & H Wire Company began a recall of FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56 on 2023-12-21. FDA classified it as Class II and gives the reason as "Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0976-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-02-02
Recalling firm: G & H Wire Company
Product: FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Product code: ECI Band, Elastic, Orthodontic
Reason for recall: Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
Root cause tag: packaging
FDA root cause: Packaging process control
Action: G&H Orthodontics issued Product Recall Notice to customers on 12/21/23 via E-mail and phone call. Letter states reason for recall, health risk and action to take: Required Action for Users: Return product for disposal. Follow-up Actions by G&H: Flexmedics intends to replace products with accurately labeled products. You may reach G&H at 1.800.526.1026 or 1.31 7.346.6655 if you have additional questions. We are open 7 AM - 7PM US Eastern Time weekdays
Quantity in commerce: 81 pk (100/pk)
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.
Product codes and lots: UDI: 10195291042642 Lot Number: 1120035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0976-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0976-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02

Product code ECI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)