Recall Z-3280-2011 · ITJ Walker, Mechanical

Invacare Corporation

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.

Date	Sep 27, 2011 (initiated Mar 2, 2011)
Status	Terminated
Reason	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
Root 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
Quantity	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 Isr
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.