RecallRadar

FDA Device recall Z-1785-2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the te…

On 2018-05-16 the FDA classified a Class II recall of Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the te… by Tp Orthodontics, citing the firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1785-2018
ClassificationClass II
Statusterminated
Initiated2018-05-01
Published2018-05-16
Last updated2026-09-13 11:54 UTC
CompanyTp Orthodontics
DistributionAL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA

Product

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.

Reason

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

Identifiers

code_info16015000, 17315000, 17715000, 18115000, 19515000, 24015000, 26515000, 30015000, 32315000, 32815000, 33515000

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1785-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.