Recall Z-1704-2012
Invacare Corporation · initiated April 6, 2012
Product
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.
Codes / lots: Model number 65960
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1704-2012
- Initiated
- April 6, 2012
- Posted by FDA
- June 5, 2012
- Terminated
- March 1, 2013
- Product code
- ITJ – Walker, Mechanical
- 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.
- Recalling firm
- Invacare Corporation, Elyria, OH