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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
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  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product UltraCongruent Tibial Insert Model 0214703
Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
Code Information All of specific lot 044843
Recalling Firm/
Plus Orthopedics
10188 Telesis Ct
San Diego CA 92121
For Additional Information Contact Natalie J. Kennel
888-741-7587 Ext. 2526
Manufacturer Reason
for Recall
Knee tibial insert is mislabeled completely as different device.
FDA Determined
Cause 2
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

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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = PLUS ORTHOPEDICS