# FDA recall Z-1791-2018

> **TP Orthodontics, Inc.** · Class II · device recall initiated 2018-05-01.

## Product

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.

## 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

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.

## Key facts

- **Recall number:** Z-1791-2018
- **Recalling firm:** TP Orthodontics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-01
- **Report date:** 2018-05-16
- **Termination date:** 2020-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** La Porte, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1791-2018

## Citation

> AI Analytics. FDA recall Z-1791-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1791-2018. Source: US FDA. Licensed CC0.

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