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U.S. Department of Health and Human Services

Class 2 Device Recall RESTORE, STAGE1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS

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  Class 2 Device Recall RESTORE, STAGE1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS see related information
Date Initiated by Firm August 25, 2017
Create Date February 27, 2018
Recall Status1 Terminated 3 on April 16, 2019
Recall Number Z-0727-2018
Recall Event ID 79110
510(K)Number K072768  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage
Implants

Keystone s implants are intended for 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 Catalog# S2400K, Lot 34276
Recalling Firm/
Manufacturer		 Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact Johanna Drzyzga
866-902-9272
Manufacturer Reason
for Recall		 The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
FDA Determined
Cause 2		 Error in labeling
Action On August 18, 2017 a letter titled "Product Action  S2400K, Stage-1 RDS Indexed Abutment, Lot 34276" was issued to customers requesting persons to review their inventory and respond if product has been used or not. A response form is requested from these customers with instruction to return any unused product. Questions or concerns can be directed to: Customer Relations: Toll Free 866-902-9272
Quantity in Commerce 20
Distribution Nationally.
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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