Z-1795-2018Class II

Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by...

Name: Z-1795-2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by...
Creator: TP Orthodontics, Inc.
Published: 2018-05-01
License: https://open.fda.gov/license/

TP Orthodontics, Inc. / initiated 2018-05-01 / Terminated / root cause: design

FDA source

TP Orthodontics, Inc. began a recall of Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube... on 2018-05-01. FDA classified it as Class II and gives the reason as "The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1795-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-01
Posted: 2018-05-10
Terminated: 2020-04-15
Recalling firm: TP Orthodontics, Inc.
Product: Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Product code: ECO Spring, Orthodontic
Reason for recall: The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Root cause tag: design
FDA root cause: Device Design
Action: On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or [email protected] for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: [email protected] FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or [email protected]
Quantity in commerce: 1
Distribution: Distributed to accounts in 20 states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. Foreign distribution to 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.
Product codes and lots: 25915000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1795-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1783-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1784-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1785-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1786-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1787-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1788-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1789-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1790-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1791-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1792-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1793-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1794-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10
Z-1795-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10

Product code ECO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)