Kuschall K Junior Manual wheelchair
FDA device recall Z-0421-2010 · posted 2009-11-25 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- 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.).
- Action taken
- 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: Recalls@Invacare.com or phone: 800-333-6900.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 20 Wheelchairs
- Distribution
- Product was distributed to the following states: CA, CO, MN, NJ, OR, PA, TX & VA and one to Canada.
- Date initiated
- 2009-06-15
- Date posted
- 2009-11-25
- Date terminated
- 2011-11-21
- Location
- Elyria, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS (K982336) | Invacare Corp. | 1998-08-21 |