| Class 2 Device Recall Keystone Dental PrimaConnex Straight Implant TC |  |
Date Initiated by Firm | March 09, 2017 |
Date Posted | April 13, 2017 |
Recall Status1 |
Terminated 3 on July 05, 2017 |
Recall Number | Z-1818-2017 |
Recall Event ID |
76782 |
510(K)Number | K051614 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product | Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm.
Catalog Number(s): 15636K |
Code Information |
Lot Number: 30214 |
Recalling Firm/ Manufacturer |
Keystone Dental Inc 154 Middlesex Tpke Burlington MA 01803-4403
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For Additional Information Contact | 781-328-3390 |
Manufacturer Reason for Recall | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272 |
Quantity in Commerce | 59 units |
Distribution | CA, IL, IN, FL, MA, MN, NJ, NV, PA, |
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 = DZE
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