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Z-1164-2021 Class II Terminated

Recalled by G & H Wire Company — Franklin, IN

FDA device recall Z-1164-2021 was initiated by G & H Wire Company on January 21, 2021 and is designated Class II. 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 … The recall status is terminated (terminated September 20, 2021). Affected quantity: 371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks).

Recall Details

Product Type: Devices
Report Date: March 10, 2021
Initiation Date: January 21, 2021
Termination Date: September 20, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks)

Product Description

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.

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.

Distribution Pattern

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.

Code Information

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