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U.S. Department of Health and Human Services

Class 2 Device Recall Wombat Living

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  Class 2 Device Recall Wombat Living see related information
Date Initiated by Firm March 28, 2019
Create Date May 11, 2019
Recall Status1 Terminated 3 on December 15, 2023
Recall Number Z-1315-2019
Recall Event ID 82571
Product Classification Chair, with casters - Product Code INM
Product 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)
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  
Recalling Firm/
Manufacturer		 R82 A/S
Parallelvej 3
Gedved Denmark
Manufacturer Reason
for Recall		 Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
FDA Determined
Cause 2		 Device Design
Action The firm notified the US importer by email on 03/28/2019. The letter explained the problem and requested that the plastic joint connecting the back to the seat base be replaced. The importer will notify the distributors (dealers) of the issue and provide the replacement kits when they arrive. The distributors (dealers) will be performing the field corrections.
Quantity in Commerce 68 units
Distribution US in the states of NC
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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