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
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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/ Manufacturer |
Keystone Dental Inc 154 Middlesex Tpke Burlington MA 01803-4403
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For Additional Information Contact | Johanna Drzyzga 866-902-9272 |
Manufacturer Reason for Recall | Abutments are unable to accept the final abutment screw |
FDA Determined Cause 2 | Other |
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 |
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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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510(K) Database | 510(K)s with Product Code = NHA
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