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.
FDA Recall Z-1704-2012 · Posted 2012-06-05
Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeITJ
Date Initiated2012-04-06
Date Terminated2013-03-01
Product Quantity1640
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.