CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Jasper Vektor, Class II Correction Appliance recalled by TP Orthodontics

TP Orthodontics is recalling Jasper Vektor, Class II Correction Appliance, distributed in 20 states. The recall was initiated on 1 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes17515000, 17615000, 25915000

Quantity recalled5

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1793-2018
FDA event ID: 79739
Recalling firm: TP Orthodontics, La Porte, IN
Classification: Class II
Status: Terminated
Recall initiated: 1 May 2018
FDA classified: 10 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 May 2018	Recall initiated by company
10 May 2018	Classified by FDA	+9 days
16 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was 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, Netherlands, New Zealand, Portugal, Singapore, and South Africa.

Alabama California Colorado Florida Hawaii Idaho Illinois Massachusetts Maine Michigan New Jersey Nevada New York Ohio Oregon Pennsylvania South Carolina Texas Utah Virginia

Questions about this recall

Is Jasper Vektor, Class II Correction Appliance recalled?

Yes. TP Orthodontics recalled Jasper Vektor, Class II Correction Appliance on 1 May 2018. The recall is Class II and its status is Terminated. Recall number Z-1793-2018.

Why was it recalled?

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

Which lots are affected?

17515000, 17615000, 25915000

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from TP Orthodontics

All 13

Reported	Class	Recall	Company	Reason	Where
16 May 2018Device	CLASS II	Jasper Vektor, Class II Correction Appliance recalled by TP Orthodontics	TP Orthodontics	Device Malfunction	20 states
16 May 2018Device	CLASS II	Jasper Vektor, Class II Correction Appliance recalled by TP Orthodontics	TP Orthodontics	Device Malfunction	20 states
16 May 2018Device	CLASS II	Jasper Vektor, Class II Correction Appliance recalled by TP Orthodontics	TP Orthodontics	Device Malfunction	20 states
16 May 2018Device	CLASS II	Jasper Vektor, Class II Correction Appliance recalled by TP Orthodontics	TP Orthodontics	Device Malfunction	20 states
16 May 2018Device	CLASS II	Jasper Vektor, Class II Correction Appliance recalled by TP Orthodontics	TP Orthodontics	Device Malfunction	20 states

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