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U.S. Department of Health and Human Services

Class 2 Device Recall FlexMedics Patient Packs

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 Class 2 Device Recall FlexMedics Patient Packssee related information
Date Initiated by FirmJanuary 21, 2021
Create DateMarch 03, 2021
Recall Status1 Terminated 3 on September 20, 2021
Recall NumberZ-1164-2021
Recall Event ID 87248
Product Classification Band, elastic, orthodontic - Product Code ECI
ProductBand, 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.
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
Recalling Firm/
Manufacturer		 G & H Wire Company
2165 Earlywood Dr
Franklin IN 46131-8879
For Additional Information ContactNichole Leahy-Glass
317-346-6655
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 Commerce371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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