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U.S. Department of Health and Human Services

Class 2 Device Recall Solara Spree GT manual wheelchair.

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  Class 2 Device Recall Solara Spree GT manual wheelchair. see related information
Date Initiated by Firm June 27, 2006
Date Posted September 20, 2006
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/
Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44035
For Additional Information Contact Janice K. Brownlee
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
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.