Reported May 16, 2018 · Terminated
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying…
TP Orthodontics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TP Orthodontics, Inc. · 100 Center Plz · La Porte, IN · 46350-9672
Is this the product you have?
- 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.
- Lot codes and dates
1601500017415000175150001771500018815000258150002651500030715000308150003151500032915000
- Amount recalled
- 119
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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