Retiro De Equipo (Recall) de Device Recall wheeled adult and junior walkers

Recall

58556

Class 2

Z-3280-2011

2011-03-02

2011-09-27

Terminated

United States

2013-07-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99590

The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. the firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the nylex fastener. consequently, over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. this scenario would res.

The firm, Invacare Corporation notified their customers of this recall/corrective action via an 'URGENT RECALL INFORMATION' letter dated April 7, 2011. The letter was sent to the customers by registered mail or Federal Express. The letter informs the customer(s) of the component defect involved and the inherent possibility that over time, a walker wheel(s) could fall off resulting in instability of the product and potential for serious injury to the user of the device. The letter provides a list of the affected units sold to each facility on an enclosed tracking sheet. It also asks that the customer: 1) Examine their stock for the presence of any of the affected walkers and to quarantine any such products found; 2) Complete an attached recall response form indicating the customers receipt and understanding of the instructions provided in the letter and to fax the completed form to the telephone number listed on the bottom of the form. The letter goes on to state that once the faxed back form is received by Invacare, the company will send the customer replacement wheels kits for all affected walkers purchased; 3) the customer is asked upon receipt of the replacement wheel kits to replace the wheels of any units still in stock and discard all of the old wheel parts removed; 4) Lastly, the customer is asked to contact their sub-account customers and notify them of the recall. If the customer have any questions concerning the instructions, call the recall support line at 1-866-567-7899.