Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. D...

FDA Device Recall #Z-0634-2014 — Class II — April 16, 2012

Recall Summary

Recall Number Z-0634-2014
Classification Class II — Moderate risk
Date Initiated April 16, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Invacare Corporation
Location Elyria, OH
Product Type Devices
Quantity 227 Wheelchairs

Product Description

Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.

Reason for Recall

The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.

Distribution Pattern

US Distribution: Michigan only.

Lot / Code Information

Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.

Other Recalls from Invacare Corporation

Recall # Classification Product Date
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.