Z-0556-2013Class II

Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged...

Name: Z-0556-2013 Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged...
Creator: Invacare Corporation
Published: 2012-11-06
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2012-11-06 / Terminated / root cause: design

FDA source

Invacare Corporation began a recall of Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used... on 2012-11-06. FDA classified it as Class II and gives the reason as "Following their receipt of several customer complaints, Invacare recalled their height adjustable walking canes. The device was recalled from distribution based on reports indicating that there is a possibility that the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0556-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-06
Posted: 2012-12-18
Terminated: 2013-08-20
Recalling firm: Invacare GmbH
Product: Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation.
Product code: KHY Cane, Safety Walk
Reason for recall: Following their receipt of several customer complaints, Invacare recalled their height adjustable walking canes. The device was recalled from distribution based on reports indicating that there is a possibility that the button which holds the cane at the desired height, may suddenly and unexpectedly compress, causing the cane to collapse and cause possible injury to the user.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Invacare, sent an "URGENT MEDICAL DEVICE RECALL (Removal)" letter dated November 6, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine their existing stock using the enclosed detailed 'Product Tracking Sheet' and quarantine any affected canes; Acknowledge receipt and understanding of the urgent recall notice and indicate the number of canes remaining in inventory on the enclosed, 'Provider Response Card;'. Fax the completed Provider Response Card to Invacare Regulatory Affairs at: 1- 440-326-3544; disassemble each cane and discard both pieces in the trash; (Disassembly instructions are also provided); and lastly, contact Invacare Customer Service at 1-800-668-2337, Monday - Friday, 8 a.m. - 8 p.m. EST, to order replacement merchandise at no charge. If you have any questions concerning these instructions, contact Invacare Customer Service at 1-800-668-2337, Monday - Friday, 8 a.m. - 6 p.m. ET.
Quantity in commerce: 38,280 canes
Distribution: Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN KS, KY, LA,MA, MD ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH,OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Australia, Puerto Rico, and Taiwan Province of China.
Product codes and lots: The Lot Codes subject to recall are: PW111201, PW120201, PW120101, PW120301, and PW120401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0556-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0556-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-18

Product code KHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)