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

FDA Device Recall #Z-0556-2013 — Class II — November 6, 2012

Recall Summary

Recall Number Z-0556-2013
Classification Class II — Moderate risk
Date Initiated November 6, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Invacare Corporation
Location Elyria, OH
Product Type Devices
Quantity 38,280 canes

Product Description

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.

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.

Distribution Pattern

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.

Lot / Code Information

The Lot Codes subject to recall are: PW111201, PW120201, PW120101, PW120301, and PW120401

Other Recalls from Invacare Corporation

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Z-1251-2024 Class II Invacare Homecare Series Bed and Invacare G-Ser... Jan 22, 2024
Z-2445-2023 Class II DOLOMITE GLOSS ROLLATOR - intended to support d... Jun 15, 2023
Z-1369-2022 Class III Invacare Platinum 5NXG Oxygen Concentrator, Mod... Jun 10, 2022
Z-1130-2022 Class II Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG... Mar 30, 2022
Z-0445-2022 Class II Invacare TDX SP2 with LiNX Gyro Power Wheelchai... Nov 12, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.