Data Foundry

Medical device recalls 2018

Jasper Vektor — Class II medical device recall Z-1791-2018

Terminated recall by TP Orthodontics, Inc., reported 2018-05-16, distributed in AL, CA, CO, FL, HI, ID, IL, MA…. The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause

Recall numberZ-1791-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTP Orthodontics, Inc., La Porte, IN, United States
Recall initiated2018-05-01
Classified2018-05-10
Reported by FDA2018-05-16
Terminated2020-04-15
DistributedAL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA
Countries outside the USAE, AU, BE, BR, CA, DE, ES, FI, FR, GB, HU, IE, IT, JP, MX, NL, NZ, PT, SG, ZA
Quantity5
Reason classesdevice malfunction
Model numbers610-533LUSED

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1791-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.