Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Guardian Mechanical walker.

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Guardian Mechanical walker. see related information
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
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
For Additional Information Contact Kevin Walls
720-962-5412
Manufacturer Reason
for Recall		 Walker wheel hubs may fracture, causing walker to collapse to one side.
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
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.
-
-