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U.S. Department of Health and Human Services

Class 2 Device Recall Leckey 4Point Pelvic Harness Belts

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  Class 2 Device Recall Leckey 4Point Pelvic Harness Belts see related information
Date Initiated by Firm April 17, 2009
Date Posted September 10, 2009
Recall Status1 Terminated 3 on May 13, 2011
Recall Number Z-2040-2009
Recall Event ID 52114
Product Classification Mechanical chair - Product Code INN
Product Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs:
a) Leckey Contour Advance Seat, Size 1, catalog 081117209;
b) Leckey Contour Advance Seat, Size 2, catalog 081117217;
c) Leckey Squiggles Saddle Seat, catalog 081326941;
d) Leckey Early Sitting System, catalog 081395193
Code Information All belts supplied on the affected seating systems between September 2007 and December 2008
Recalling Firm/
Manufacturer		 Patterson Medical Holdings, Inc.
1000 Remington Blvd Ste 210
Bolingbrook IL 60440-5116
For Additional Information Contact Carla Dreher
800-228-3693 Ext. 8724
Manufacturer Reason
for Recall		 The plastic buckles on the hip belts of the 4-Point Pelvic Harness may break.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Sammons Preston, the U.S. agent for James Leckey Design Ltd., issued recall letters dated 4/17/09 to all of their customers who purchased the Leckey 4-Point Pelvic Harness, used in the Leckey Contoured Advance Seat, Leckey Early Sitting System and the Leckey Squiggles Saddle Seat, informing them that the manufacturer, James Leckey Design Ltd., is recalling the harness because the pelvic belt buckle may not lock securely and/or break. A copy of the Urgent Field Safety Notice dated 1/28/09 issued by Leckey in the United Kingdom was included with the Sammons letter. The customers were advised to be vigilant and check the hip belts daily to ensure that the user is secure in their seating system until the replacement hip belt is received. The accounts were requested to contact Carla Dreher at 1-800-288-3693, ext. 8724 for instructions on how to receive a replacement hip belt.
Quantity in Commerce 226 belts
Distribution Nationwide and Canada
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.
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