Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 9...

FDA Device Recall #Z-1315-2019 — Class II — March 28, 2019

Recall Summary

Recall Number Z-1315-2019
Classification Class II — Moderate risk
Date Initiated March 28, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm R82 A/S
Location Gedved
Product Type Devices
Quantity 68 units

Product Description

Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)

Reason for Recall

Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.

Distribution Pattern

US in the states of NC

Lot / Code Information

953121-00, Serial Numbers: 396362, 408283, 420577 953126-00, Serial Numbers: 388456 953131-00, Serial Numbers: 458258 953132-00, Serial Numbers: 384942, 385290, 388501, 418621 935135-00, Serial Numbers: 424406, 424407, 424990, 424991, 427314, 427315, 427316, 427317, 427318, 427319 935136-00, Serial Numbers: 395926, 438528, 442346 953211-00, Serial Numbers: 388448 953221-00, Serial Numbers: 397966, 398981, 408859, 415846, 415847, 418207, 418208, 418209, 421084, 423947, 439833, 448668, 457473 953222-00, Serial Numbers: 389328, 390937, 398116, 401269, 401270, 401271, 403002, 403003, 407903, 407904, 408008, 447674, 447675, 447676, 466069, 472310, 472311 953225-00, Serial Numbers: 449990 953226-00, Serial Numbers: 386225, 450151 953231-00, Serial Numbers: 408215, 408595, 462750 953232-00, Serial Numbers: 402148, 404886, 405148, 405157, 424014, 432987, 459042 953236-00, Serial Numbers: 386256, 412649

Other Recalls from R82 A/S

Recall # Classification Product Date
Z-0569-2022 Class II R82 by ETAC Push Brace for High-Low Dec 8, 2021
Z-1858-2020 Class II Chest Support for R82 Mustang, Model Numbers: ... Mar 6, 2020
Z-0441-2019 Class II Heron toilet and bath chair Model 880505-01 & 8... Jun 30, 2017

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.