TP Orthodontics recalls Jasper Vek: Class II Correction Appliance (Part No. 610-533R) due to reported breakage in patients' mouths causing injury. 106 complaints received.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
TP Orthodontics recalls their Jasper Vektor Class II Correction Appliance (Part No. 610-533R) because it has broken in patients' mouths 106 times, potentially causing injury. This recall affects orthodontic patients using the device for correcting class 2 malocclusions.
The device can break inside the patient's mouth, leading to potential injury. This has been reported in 106 complaints where the appliance broke during use.
Orthodontic patients using the Jasper Vektor appliance for correcting class 2 malocclusions are most at risk. The recall applies to devices sold with part numbers 17515000, 17615000, and 25915000.
Check for the part number 610-533R on the appliance. The device was sold with serial numbers 17515000, 17615000, or 25915000.
Inspect the device for signs of breakage, such as cracks or pieces inside the mouth.
TP Orthodontics has received 106 complaints of the device breaking in patients' mouths, which can cause injury.
Look for part number 610-533R and serial numbers 17515000, 17615000, or 25915000 on the appliance.
Check the appliance for signs of breakage. If it's broken, stop using it and contact TP Orthodontics for further instructions.
We’ve drafted a message you can send TP Orthodontics to request your refund or repair — edit it as you like.
Subject: Recall Z-1793-2018 — TP Orthodontics TP Orthodontics Hello, I own a TP Orthodontics that is covered by recall Z-1793-2018 from TP Orthodontics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
