TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 10 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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Severe because the source text explicitly states that device breakage may cause injury to the patient, which aligns with the rubric criterion for significant injury reports or risk-of-harm products.
Plain-English summary
TP Orthodontics, Inc. is recalling 10 units of the Jasper Vektor, Class II Correction Appliance, Part No. 610-527. 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 company states that device breakage may cause injury to the patient.
The affected units were distributed to accounts in 20 U.S. 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 specific lot codes associated with the recall are 16015000, 18115000, 18815000, 25715000, and 30215000.
The recalled product
- Product
- Jasper Vektor, Class II Correction Appliance, Part No. 610-527 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
- 10
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 (5)
- 16015000
- 18115000
- 18815000
- 25715000
- 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
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