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Class 2 Device Recall Keystone PrimaConnex Tapered Implant TC |
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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
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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
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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
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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 and Original Applicant = LIFECORE BIOMEDICAL, INC.
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