TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 108 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 involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
TP Orthodontics, Inc. is recalling 108 units of the Jasper Vektor, Class II Correction Appliance, Part No. 610-500. This orthodontic device is used to correct Class 2 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 15915000, 17615000, 17715000, 18015000, 18115000, 18915000, 20315000, 23915000, 24515000, 25715000, 25815000, 26515000, 29415000, 29315000, and 32915000. Patients and healthcare providers should contact TP Orthodontics, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Jasper Vektor, Class II Correction Appliance, Part No. 610-500 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
- 108
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 (15)
- 15915000
- 17615000
- 17715000
- 18015000
- 18115000
- 18915000
- 20315000
- 23915000
- 24515000
- 25715000
- 25815000
- 26515000
- 29415000
- 29315000
- 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
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