Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable r...

FDA Device Recall #Z-2073-2015 — Class II — June 15, 2015

Recall Summary

Recall Number Z-2073-2015
Classification Class II — Moderate risk
Date Initiated June 15, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Etac Supply Center Ab
Location Anderstorp, N/A
Product Type Devices
Quantity 25 units

Product Description

Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.

Reason for Recall

The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become unsteady.

Distribution Pattern

Nationwide Distribution including GA, CT and PA.

Lot / Code Information

Serial numbers higher than 224017

Other Recalls from Etac Supply Center Ab

Recall # Classification Product Date
Z-2381-2015 Class II Etac Relax wall mounted shower seat The Etac R... Jul 12, 2015
Z-1807-2013 Class II Swift Mobil shower chair, Swift Mobil 160 showe... May 23, 2013
Z-2014-2012 Class II Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac... Apr 6, 2012

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.