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Class 2 Device Recall |
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Date Initiated by Firm |
January 04, 2005 |
Date Posted |
February 15, 2005 |
Recall Status1 |
Terminated 3 on March 03, 2005 |
Recall Number |
Z-0540-05 |
Recall Event ID |
30807 |
510(K)Number |
K022204
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Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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Product |
UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm |
Code Information |
All of specific lot 044843 |
Recalling Firm/ Manufacturer |
Plus Orthopedics 10188 Telesis Ct San Diego CA 92121
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For Additional Information Contact |
Natalie J. Kennel 888-741-7587 Ext. 2526
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Manufacturer Reason for Recall |
Knee tibial insert is mislabeled completely as different device.
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FDA Determined Cause 2 |
Other |
Action |
PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert. |
Quantity in Commerce |
10, 1 is implanted. |
Distribution |
California, Idaho, Illinois, Wisconsin, Oregon |
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 = JWH and Original Applicant = PLUS ORTHOPEDICS
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