FDAFDA · Food and drugs·Recall number Z-1788-2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Published May 16, 2018 · Recall initiated: May 1, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- TP Orthodontics, Inc.
- Distributor
- 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.
- Lot
- 25715000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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