Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1315-2019Class II

Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00...

R82 a/S / initiated 2019-03-28 / Terminated / root cause: design

R82 A/S began a recall of 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... on . FDA classified it as Class II and gives the reason as "Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1315-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
R82 a/S
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)
Product code
INM Chair, With Casters
Reason for recall
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Root cause tag
design
FDA root cause
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
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1315-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1315-2019Class IITerminatedVoluntary: Firm initiated