Date Initiated by Firm |
July 15, 2004 |
Date Posted |
August 18, 2004 |
Recall Status1 |
Terminated 3 on November 07, 2005 |
Recall Number |
Z-1379-04 |
Recall Event ID |
29670 |
Product Classification |
Component, External, Limb, Ankle/Foot - Product Code ISH
|
Product |
Modular Knee Joint with Friction Brake |
Code Information |
No lot numbers are used. Recall covers patients who were fit with either of the products between March 1, 2004 and July 9, 2004. |
Recalling Firm/ Manufacturer |
Bock,Otto,Orthopedic Ind,Inc 3000 Xenium Ln N Minneapolis MN 55441-2661
|
For Additional Information Contact |
Stephen A. Carr 763-489-5106
|
Manufacturer Reason for Recall |
Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the braking performance of the knee to malfunction.
|
FDA Determined Cause 2 |
Other |
Action |
The braking plate of the knee may become dislodged, which may cause the braking performance of the knee to malfunction. |
Quantity in Commerce |
457 devices |
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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