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.
What this means for you
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.
- Hazard
- 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
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 →Related recalls
Same manufacturer · TP Orthodontics, Inc.
See all →- HighTP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
FDA (Devices) · 2018-05-16
- HighTP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
FDA (Devices) · 2018-05-16
- HighTP Orthodontics Recalls Jasper Vektor Class II Correction Appliance
FDA (Devices) · 2018-05-16
- HighTP Orthodontics Recalls Jasper Vektor Class II Correction Appliance
FDA (Devices) · 2018-05-16
- HighTP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
FDA (Devices) · 2018-05-16
Same hazard · device breakage
See all →- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01