| Class 2 Device Recall Keystone PrimaConnex Tapered Implant TC | |
Date Initiated by Firm | March 11, 2013 |
Date Posted | March 20, 2013 |
Recall Status1 |
Terminated 3 on September 26, 2013 |
Recall Number | Z-0973-2013 |
Recall Event ID |
64633 |
510(K)Number | K051614 |
Product Classification |
Accessories, implant, dental, endosseous - Product Code NDP
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Product | PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm
Catalog Number: l5613K.
Implants in support for fixed bridgework. |
Code Information |
Lot Number: 12857 |
Recalling Firm/ Manufacturer |
Keystone Dental Inc 144 Middlesex Tpke Burlington MA 01803-4403
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For Additional Information Contact | Jamie Picariello 781-328-3390 |
Manufacturer Reason for Recall | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled |
FDA Determined Cause 2 | Packaging process control |
Action | Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned. |
Quantity in Commerce | 120 units |
Distribution | Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France. |
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 = NDP
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