Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0421-2010

Kuschall K Junior Manual wheelchair

Invacare GmbH / initiated 2009-06-15 / Terminated / root cause: design

Invacare Corporation began a recall of Kuschall K Junior Manual wheelchair on . The reason FDA records is "The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.)". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0421-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Kuschall K Junior Manual wheelchair
Product code
IOR Wheelchair, Mechanical
Reason for recall
The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.).
Root cause tag
design
FDA root cause
Device Design
Action
The firm contacted their customers by telephone and then sent a recall notification letter to each customer on 6/15/2009. Questions are directed to email: [email protected] or phone: 800-333-6900.
Quantity in commerce
20 Wheelchairs
Distribution
Product was distributed to the following states: CA, CO, MN, NJ, OR, PA, TX & VA and one to Canada.
Product codes and lots
Model Numbers: 0806281234, 0806893858, 0806135534, 0806161578, 0806237627, 0806268153, 0806268154, 0806309590, 0806315524, 0806351557, 0806568768, 0806591793. 0806670117, 0806724855, 0806731287, 0806773921, 0807007811, 0807019897, 0807062866, 0807110193