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TP Orthodontics, Inc. recalls Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying li
Recalled May 16, 2018 · FDA recall Z-1789-2018 · TP Orthodontics
Hazard
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient. · FDA Class II
Units
7
Sold at
Distributed to accounts in 20 states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Germany, Spain, Finland, France, Great Britain, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Singapore, and South Africa.
Description
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Manufacturer(s)
TP Orthodontics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →