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U.S. Department of Health and Human Services

Class 2 Device Recall PrimaConnex Implant System

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  Class 2 Device Recall PrimaConnex Implant System see related information
Date Initiated by Firm June 20, 2017
Create Date February 14, 2018
Recall Status1 Terminated 3 on April 09, 2018
Recall Number Z-0608-2018
Recall Event ID 79040
510(K)Number K051614  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K

pRODUCT Usage:
Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
Code Information REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022
Recalling Firm/
Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact Johanna Drzyzga
Manufacturer Reason
for Recall
Abutments are unable to accept the final abutment screw
FDA Determined
Cause 2
Action On June 20, 2017 Keystone Dental telephoned impacted customers and advised them of the problem. On July 3rd, 2017 Keystone Dental issued notices (dated June 29, 2017) and response forms to customers via Fed Ex. Customers were encouraged to complete and return the response form attached form to confirm receipt of the replacement product and that lot 33006 can be returned to Keystone Dental. Customers with questions can call Johanna Drzyzga, Customer Relations Manager at 866-902-9272.
Quantity in Commerce 20 units
Distribution US Nationwide Distribution in the states of ND, NJ & MA
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 = NHA and Original Applicant = LIFECORE BIOMEDICAL, INC.