TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
FDA device recall Z-2657-2014 · posted 2014-09-17 · Terminated
Recall details
- Recalling firm
- Motion Concepts
- Reason for recall
- Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).
- Action taken
- URGENT RECALL NOTIFICATION Letters (dated 8/26/2014) were sent to customers on 8/26/14 via Federal Express. Motion Concepts is requesting that all customers that have purchased a Motion Concepts TRx Vertical Positioner system in between June 2011 - May 2014 to make arrangements for replacement of the knee support mount in accordance with the instructions enclosed in the letter. For questions, please contact us at 905-695-0134.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- US: 59 units
- Distribution
- US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA.
- Date initiated
- 2014-08-28
- Date posted
- 2014-09-17
- Date terminated
- 2015-06-03
- Location
- Concord, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRX VERTICAL POSITIONER (K023426) | Motion Concepts | 2002-11-21 |