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Class 2 Device Recall FlexMedics Patient Packs |
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Date Initiated by Firm |
January 21, 2021 |
Create Date |
March 03, 2021 |
Recall Status1 |
Terminated 3 on September 20, 2021 |
Recall Number |
Z-1164-2021 |
Recall Event ID |
87248 |
Product Classification |
Band, elastic, orthodontic - Product Code ECI
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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. |
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
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For Additional Information Contact |
Nichole Leahy-Glass 317-346-6655
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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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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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