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U.S. Department of Health and Human Services

Class 2 Device Recall MPF/ MPF GII / VKS

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  Class 2 Device Recall MPF/ MPF GII / VKS see related information
Date Initiated by Firm June 03, 2005
Date Posted June 22, 2005
Recall Status1 Terminated 3 on July 13, 2005
Recall Number Z-0924-05
Recall Event ID 32337
510(K)Number K022204  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
Code Information Lot / Unit Code: 044152
Recalling Firm/
Plus Orthopedics USA
10188 Telesis Ct
San Diego CA 92121-4779
For Additional Information Contact Natalie J. Kennel
888-741-7587 Ext. 2526
Manufacturer Reason
for Recall
Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.
FDA Determined
Cause 2
Action Notification was made by telephone beginning June 2, 2005. Recall is on-going.
Quantity in Commerce 54 USA 78 Europe
Distribution Idaho, Texas and Virginia
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