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Class 2 Device Recall Neodent |
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Date Initiated by Firm |
August 11, 2014 |
Date Posted |
December 22, 2014 |
Recall Status1 |
Terminated 3 on February 06, 2015 |
Recall Number |
Z-0839-2015 |
Recall Event ID |
69835 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product |
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function |
Code Information |
Lot Number: 800115427 |
Recalling Firm/ Manufacturer |
Instradent USA, Inc. 60 Minuteman Rd Andover MA 01810-1008
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For Additional Information Contact |
855-412-8883 Ext. 6366
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Manufacturer Reason for Recall |
Product not approved for use in the US
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FDA Determined Cause 2 |
No Marketing Application |
Action |
Neodent iniated the recall by telephone and follow-up Recall Notification letter with Confirmation form onAugust 14, 2014, requesting the return of unused product. Customers with questions were instructed to call 978-809-6275.
For questions regarding this recall call 855-412-8883, ext 6366. |
Quantity in Commerce |
13 units |
Distribution |
Nationwide Distribution including AZ, CA, NY, and MA. |
Total Product Life Cycle |
TPLC Device Report
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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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