FDA recall Z-1315-2019

R82 A/S · Class II · 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)

Reason for recall

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

Distribution

US in the states of NC

Key facts

Status
Terminated
Initiation date
2019-03-28
Report date
2019-05-22
Termination date
2023-12-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gedved, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1315-2019