Class 2 Device Recall wheeled adult and junior walkers

• Date Initiated by Firm: March 02, 2011
• Date Posted: September 27, 2011
• Recall Status: Terminated on July 02, 2013
• Recall Number: Z-3280-2011
• Recall Event ID: 58556
• Product Classification: Walker, mechanical - Product Code ITJ
• Product: Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box.; ; Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking.
• Code Information: All 6240-5F and 6240-JR5F wheeled walkers distributed by the firm between 12/15/2010 and 3/4/2011, are subject to recall/correction.
• Recalling Firm/ Manufacturer: Invacare Corporation; 1200 Taylor St; Elyria OH 44035-4190
• For Additional Information Contact: 440-329-6000
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 12,764 walkers were distributed.
• Distribution: Worldwide Distribution - USA (nationwide: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, including Puerto Rico and countries of Canada, Columbia, and Israel.
• 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.