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U.S. Department of Health and Human Services

Class 2 Device Recall Cane

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 Class 2 Recall
Cane
see related information
Date Posted December 18, 2012
Recall Status1 Terminated on August 20, 2013
Recall Number Z-0556-2013
Recall Event ID 63775
Product Classification Cane, Safety Walk - Product Code KHY
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.
Code Information The Lot Codes subject to recall are: PW111201, PW120201, PW120101, PW120301, and PW120401
Recalling Firm/
Manufacturer
Invacare Corporation
1200 Taylor St
Elyria, Ohio 44035-6248
For Additional Information Contact Sean Kharche
440-329-6595
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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