Recall Z-1315-2019— R82 A/S
Class II · Terminated
Class II FDA medical device recall by R82 A/S, initiated 2019-03-28, terminated 2023-12-15. FDA's recall record names no specific 510(k) clearance for this event. 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). Reason: Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat..
- Recalling firm
- R82 A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-28
- Terminated
- 2023-12-15
- Firm location
- Gedved, Denmark
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.