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U.S. Department of Health and Human Services

Class 2 Device Recall Jasper Vektor

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  Class 2 Device Recall Jasper Vektor see related information
Date Initiated by Firm May 01, 2018
Create Date May 10, 2018
Recall Status1 Terminated 3 on April 15, 2020
Recall Number Z-1785-2018
Recall Event ID 79739
Product Classification Spring, orthodontic - Product Code ECO
Product Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Code Information 16015000, 17315000, 17715000, 18115000, 19515000, 24015000, 26515000, 30015000, 32315000, 32815000, 33515000
Recalling Firm/
Manufacturer		 TP Orthodontics, Inc.
100 Center Plz
La Porte IN 46350-9672
For Additional Information Contact Ms. Sandra Hoefer
800-348-8856 Ext. 3334
Manufacturer 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.
FDA Determined
Cause 2		 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 info@tportho.com 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: info@tportho.com 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 info@tportho.com
Quantity in Commerce 126
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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