FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1704-2012
- Recalling firm
- Invacare Corporation
- 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.
- Status
- Terminated
- Initiated
- 2012-04-06
- Posted
- 2012-06-05
- Terminated
- 2013-03-01
- 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.
- Lot, serial or model codes
- Model number 65960
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITJ
- Firm FEI
- 3002889431
- Firm city
- Elyria
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28