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U.S. Department of Health and Human Services

Class 2 Device Recall Neodent

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 Class 2 Device Recall Neodentsee related information
Date Initiated by FirmAugust 11, 2014
Date PostedDecember 22, 2014
Recall Status1 Terminated 3 on February 06, 2015
Recall NumberZ-0839-2015
Recall Event ID 69835
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductNeodent 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
For Additional Information Contact
855-412-8883 Ext. 6366
Manufacturer Reason
for Recall		Product not approved for use in the US
FDA Determined
Cause 2		No Marketing Application
ActionNeodent 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 Commerce13 units
DistributionNationwide Distribution including AZ, CA, NY, and MA.
Total Product Life CycleTPLC 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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