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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/
Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact
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.