Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional

FDA device recall Z-1704-2012 · posted 2012-06-05 · Terminated

Recall details

Recalling firm

Invacare Corporation

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

ITJ

Quantity affected

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,

Date initiated

2012-04-06

Date posted

2012-06-05

Date terminated

2013-03-01

Location

Elyria, OH