Reported Mar 10, 2021 · Terminated
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy…
G & H Wire Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: G & H Wire Company · 2165 Earlywood Dr · Franklin, IN · 46131-8879
Is this the product you have?
- Band, Elastic
- Orthodontic - Product UsageOrthodontic 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
- Lot codes and dates
- Part Number
AMD36AMD56AMH14AMH18AMH36LFH14LFH36LFM14LFM36
- Lot Number
802028811671811672811673813660813666813669822724827161827172827173830878832605835151835158
- Part Number
- Amount recalled
- 371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new G & H Wire Company recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.