G & H Wire Company recalls orthodontic elastic bands (AMD36, AMD56, etc.) due to potential misuse risks if label not read, causing discomfort or band breakage.
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.
G & H Wire Company recalls certain orthodontic elastic bands because using them without reading the label may cause the band to break or cause discomfort. This is a misuse risk, not a product defect.
If the elastic band is too small for the patient's needs and the label is not read, the band may break. This can cause temporary discomfort but does not typically lead to serious injury.
Orthodontic patients using the recalled elastic bands. Those who apply the bands without checking the label are most at risk of temporary discomfort or band breakage.
Check for part numbers AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36. Lot numbers include 802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158.
Check the product label to ensure it matches the correct size for your treatment needs.
The recall is due to a potential misuse risk if the label is not read, which could cause the band to break or cause temporary discomfort.
Part numbers AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36.
Lot numbers 802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158.
We’ve drafted a message you can send G & H Wire Company to request your refund or repair — edit it as you like.
Subject: Recall Z-1164-2021 — G & H Wire Company G & H Wire Company Hello, I own a G & H Wire Company that is covered by recall Z-1164-2021 from G & H Wire Company. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
