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