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

FDA device recall Z-0556-2013 · posted 2012-12-18 · Terminated

Recall details

Recalling firm

Invacare Corporation

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KHY

Quantity affected

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

Date initiated

2012-11-06

Date posted

2012-12-18

Date terminated

2013-08-20

Location

Elyria, OH