FDA-Device2018-05-16Class II
Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
TP Orthodontics, Inc.
Hazard
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Sold states
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.
Affected count
108
Manufactured in
100 Center Plz, N/A, La Porte, IN, United States
Products
Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1783-2018Don't want to check this manually?
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