Z-1164-2021Class II

Band, Elastic, Orthodontic -

Name: Z-1164-2021 Band, Elastic, Orthodontic -
Creator: G & H Wire Company
Published: 2021-01-21
License: https://open.fda.gov/license/

G & H Wire Company / initiated 2021-01-21 / Terminated / root cause: manufacturing process

FDA source

G & H Wire Company began a recall of Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth... on 2021-01-21. FDA classified it as Class II and gives the reason as "The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1164-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-21
Posted: 2021-03-03
Terminated: 2021-09-20
Recalling firm: G & H Wire Company
Product: Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.
Product code: ECI Band, Elastic, Orthodontic
Reason for recall: The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 1/21/2021, G&H Orthodontics issued a Product Recall Notice to customers via email notifying affected users of a voluntary recall for FlexMedics Patient Elastic Packs. A labelling change that resulted in the color scheme of the FlexMedics Patient Packs product to be updated which was not intended and could result in consumer confusion and/or patient discomfort.
Quantity in commerce: 371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks)
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, CT, FL, IL, KY, MI, MN, MS, MT, NH, NJ, NY, NC, TN, TX, UT, VT, WA, WV, AR, IL, and the countries of Spain, Netherlands, New Zealand, Germany, France, Czech Republic, Greece, Poland, Thailand, Belgium, Denmark, United Kingdom, Canada.
Product codes and lots: Part Number: AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36. Lot Number: 802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1164-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1164-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-10	2021-03-03

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)