Recall Z-1704-2012 · ITJ Walker, Mechanical

Invacare Corporation

Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking.

Date	Jun 5, 2012 (initiated Apr 6, 2012)
Status	Terminated
Reason	Adverse event data prompted testing of device, which revealed that the rod supporting the knee pad was not made to specifications. Upon placing a load on the knee pad, the rod may break or bend causing the walker to collapse. As a result, the user may fall.
Root cause	Nonconforming Material/Component
Action	Invacare notified all consignees and distributors with a "Urgent: Recall Information" letter dated May 16, 2012. The product issue was described and recommended actions were provided to customers. Questions were directed to 1-888-257-7912.
Quantity	1640
Distribution	Worldwide Distribution--USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of China.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.