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Zimma Walking Frames fitted with Wheeled Extension Legs

Notice type: Advisory

Date: 18/09/2013

  

Product name or type:
Zimma Walking Frames fitted with Wheeled Extension Legs

Reference:
SN2013(12)

Manufacturer Or Supplier:
Invacare Ireland Limited

Target Audience:
General Public 
Hospital CEOs 
Risk Managers 
Procurement Managers 
Loan Store Managers 
HSE Offices 
Community Care Centres 
Occupational Therapists 
Community Care Managers 
Community Therapists 
Physiotherapists 
Health Visitors 
Carers 
Educational Establishments

Problem Or Issue:
Invacare have been made aware of a potential problem with Invacare Zimma Walking Frames fitted with wheeled extension legs.

Background Information Or Related Documents:
Invacare received reports that the plastic moulded wheel axle has fractured when subjected to heavy loading. This problem affects two lot numbers of Zimma Walking Frames, supplied between the 1st November 2011 and 30th April 2012. The affected lot numbers are 2011-09 and 2012-01. 

To address this issue, Invacare are replacing the suspect wheeled extension legs. Full details of the corrective action can be found in the attached field safety notice issued by Invacare. 

Invacare and their Irish distributor Healthcare 21 have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action. There are approximately 156 Zimma Walking Frames on the Irish market, which require an upgrade.

Zimma Walking Frames fitted with Wheeled Extension Legs Document

Actions To Be Taken:
The IMB advises that users: 

1. Ensure the appropriate personnel are made aware of this notice. 

2. Identify the location of all affected walking frames 

3. If you / your institution have affected walking frames, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.

Further Information:
Enquiries to the distributor should be addressed to: 

Elaine Keating 
Unit 5, Westpoint Buildings 
Westpoint Business Park 
Ballincollig 
Cork 

Telephone: 01- 8855551 
Fax: 01- 8855558 
Email: ekeating@hc21.ie 

Enquiries to the manufacturer should be addressed to: 

Neil Harvey 
Invacare Ireland Limited 
5 Seatown Business Campus 
Seatown Road 
Swords 
Co. Dublin 

Telephone: 01-8107084 
Fax: 01-8107085 
Email: nharvey@invacare.com 

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie


Please click here to view a PDF version of this safety notice
Please click here to view a copy of the FSN

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