TP Orthodontics, Inc. recalls Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying li…

Recall date

May 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1792-2018

FDA classification

Class II

Brand / firm

TP Orthodontics, Inc.

Sold / distributed

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, Netherl…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.