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U.S. Department of Health and Human Services

Class 2 Device Recall Keystone Dental PrimaConnex Straight Implant TC

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  Class 2 Device Recall Keystone Dental PrimaConnex Straight Implant TC see related information
Date Initiated by Firm September 15, 2016
Date Posted October 21, 2016
Recall Status1 Terminated 3 on January 03, 2017
Recall Number Z-0299-2017
Recall Event ID 75224
510(K)Number K051614  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm.
Product code:15613K
Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
Code Information Lot # 27714
Recalling Firm/
Manufacturer		 Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact
781-328-3390
Manufacturer Reason
for Recall		 Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
FDA Determined
Cause 2		 Packaging process control
Action Keystone Dental initially called all customers on September 15, 2016. Forms were completed to document these calls. In addition a letter has been sent via Federal Express/or hand delivered on September 19, 2016, to all distributors and customers. Customers with questions were instructed to contact Customer Relations. For questions regarding this recall call 781-328-3390.
Quantity in Commerce 55 units
Distribution Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = LIFECORE BIOMEDICAL, INC.
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