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Class 2 Device Recall Guardian Mechanical walker. |
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Date Initiated by Firm |
June 30, 2006 |
Date Posted |
August 24, 2006 |
Recall Status1 |
Terminated 3 on July 20, 2011 |
Recall Number |
Z-1420-06 |
Recall Event ID |
35786 |
Product Classification |
walker, mechanical - Product Code ITJ
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Product |
Guardian Walker, Models 30751W, 30757W, 30758W, Made in China by A&E Machinery Industry Co., Ltd. |
Code Information |
Models 30751W, 30757W, 30758W. Lots 0603, 0604, 0605. |
Recalling Firm/ Manufacturer |
A & E Industries, Ltd. Shenghui, South Road, Nantou Town, Zhong Shan City Guangdong China
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For Additional Information Contact |
Kevin Walls 720-962-5412
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Manufacturer Reason for Recall |
Walker wheel hubs may fracture, causing walker to collapse to one side.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on 06/30/2006. |
Quantity in Commerce |
32,636 units. |
Distribution |
Worldwide distribution --- USA and countries of Bangladesh, Chile, Japan, and Mexico |
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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