Agency classClass IIOur severity:High FDA (Devices)·Z-1792-2018·Announced 2018-05-16

TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

TP Orthodontics is recalling 5 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as High because the source text identifies a risk of harm (injury from device breakage) without reporting specific confirmed injuries or fatalities, aligning with the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

TP Orthodontics, Inc. is recalling five units of the Jasper Vektor, Class II Correction Appliance, Part No. 610-536. This medical device is used to correct Class II malocclusions by applying light forces to the teeth using a tube, arch wire, and stops.

The recall was initiated after the firm received 106 complaints regarding the device breaking in the patient's mouth. The company states that device breakage may cause injury to the patient.

The affected units were distributed to accounts in 20 U.S. states: Alabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, and Virginia. The devices were also distributed to foreign accounts in the 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. The specific lot codes associated with the recall are 18915000, 19515000, 26515000, and 30215000.

The recalled product

Product: 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.
Manufacturer: TP Orthodontics, Inc.
Category: Medical Device — Orthodontic Appliance
Hazard: device-breakage
injury
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

18915000
19515000
26515000
30215000

Distribution

Distributed in 20 states:

Part of a larger recall action

This product is one of 13 recalled by TP Orthodontics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Same manufacturer · TP Orthodontics, Inc.

See all →

High
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
FDA (Devices) · 2018-05-16
High
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
FDA (Devices) · 2018-05-16
High
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliance
FDA (Devices) · 2018-05-16
High
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliance
FDA (Devices) · 2018-05-16
High
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
FDA (Devices) · 2018-05-16

Same hazard · device breakage