| Date Initiated by Firm |
June 27, 2006 |
| Date Posted |
September 20, 2006 |
| Recall Status1 |
Terminated 3 on October 11, 2007 |
| Recall Number |
Z-1511-06 |
| Recall Event ID |
35772 |
| 510(K)Number |
K012370
|
| Product Classification |
wheelchair - Product Code IOR
|
| Product |
Solara Spree XT (SPRXT) manual wheelchair. |
| Code Information |
06FE009232 |
Recalling Firm/
Manufacturer |
Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44035
|
| For Additional Information Contact |
Janice K. Brownlee
440-329-6000
|
Manufacturer Reason
for Recall |
The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
|
FDA Determined
Cause 2 |
Other |
| Action |
The recalling firm notified their consignees in a letter dated 6/26/06. |
| Quantity in Commerce |
6 wheelchairs |
| Distribution |
Nationwide and Canada. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = IOR and Original Applicant = INVACARE CORP.
|
