TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 119 Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, 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 involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
TP Orthodontics, Inc. is recalling 119 units of the Jasper Vektor, Class II Correction Appliance, Part No. 610-533. This orthodontic 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 source text states that device breakage may cause injury to the patient.
The affected units were distributed to accounts in 20 U.S. states and to various foreign countries. The specific lot codes associated with the recall are 16015000, 17415000, 17515000, 17715000, 18815000, 25815000, 26515000, 30715000, 30815000, 31515000, and 32915000. Patients and providers should contact their orthodontist or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Jasper Vektor, Class II Correction Appliance, Part No. 610-533 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
- 119
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 (11)
- 16015000
- 17415000
- 17515000
- 17715000
- 18815000
- 25815000
- 26515000
- 30715000
- 30815000
- 31515000
- 32915000
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
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- HighTP Orthodontics Recalls Jasper Vektor Class II Correction Appliance
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- HighTP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
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