TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because the devices 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 FDA Class II, and the source text indicates a risk of injury from device breakage without reporting specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TP Orthodontics, Inc. is recalling 7 units of the Jasper Vektor, Class II Correction Appliance, Part No. 610-530L. This medical 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 US states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. 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 source text does not specify instructions for consumers or patients regarding the recall.
The recalled product
- Product
- Jasper Vektor, Class II Correction Appliance, Part No. 610-530L 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
- 7
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 (2)
- 22015000
- 25715000
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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