La Porte, IN, United States
TP Orthodontics, Inc. recalls
1 recall recorded since 2018, most recently on 1 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 May 2018
- Terminated
- 15 April 2020
- Reason
- The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- Distribution
- 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, Netherla
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1788-2018, Z-1791-2018, Z-1794-2018, Z-1786-2018, Z-1785-2018, Z-1787-2018, Z-1790-2018, Z-1793-2018, Z-1789-2018, Z-1792-2018, Z-1783-2018, Z-1784-2018 and 1 more
- 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.
- Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
- Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
- Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
- Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
- Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
- Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
- 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.
- and 5 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.