Home / Recalls / TP Orthodontics, Inc. / Z-1793-2018

Z-1793-2018 Class II Terminated

Recalled by TP Orthodontics, Inc. — La Porte, IN

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
May 1, 2018
Termination Date
April 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5

Product Description

Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

Reason for Recall

The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.

Distribution Pattern

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.

Code Information

17515000, 17615000, 25915000

Other recalls by TP Orthodontics, Inc.

  • Z-1787-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correct (May 1, 2018)
  • Z-1795-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correct (May 1, 2018)
  • Z-1792-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcti (May 1, 2018)
  • Z-1784-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcti (May 1, 2018)
  • Z-1789-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correct (May 1, 2018)
  • Z-1783-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcti (May 1, 2018)
  • Z-1788-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correct (May 1, 2018)
  • Z-1791-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcti (May 1, 2018)
  • Z-1794-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correct (May 1, 2018)
  • Z-1790-2018 Class II — Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correct (May 1, 2018)