| Date Initiated by Firm | June 27, 2006 |
|---|
| Date Posted | September 20, 2006 |
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| Recall Status1 |
Terminated 3 on October 11, 2007 |
| Recall Number | Z-1510-06 |
|---|
| Recall Event ID |
35772 |
| 510(K)Number | K012370 |
|---|
| Product Classification |
wheelchair - Product Code IOR
|
| Product | Solara Spree GT manual wheelchair. |
|---|
| Code Information |
06EE011382, 06FE000065, 06FE001632, 06FE001635, 06FE006693, 06FE007246 |
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 |
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| Action | The recalling firm notified their consignees in a letter dated 6/26/06. |
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| Quantity in Commerce | 6 wheelchairs |
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| Distribution | Nationwide and Canada. |
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| 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
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