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Recall Observatory FDA recall evidence

Device 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)

Z-1315-2019

March 28, 2019

Class II

Product summary

Firm
R82 A/S
Event
Event 82571
Status
Terminated
Classification
Class II
Quantity
68 units
Official record key
device-enforcement:Z-1315-2019

Official wording

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

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

Distribution pattern: US in the states of NC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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