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U.S. Department of Health and Human Services

Class 2 Device Recall Solara 2G manual wheelchair.

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 Class 2 Device Recall Solara 2G manual wheelchair.see related information
Date Initiated by FirmJune 27, 2006
Date PostedSeptember 20, 2006
Recall Status1 Terminated 3 on October 11, 2007
Recall NumberZ-1509-06
Recall Event ID 35772
510(K)NumberK012370 
Product Classification wheelchair - Product Code IOR
ProductSolara 2G manual wheelchair.
Code Information 06EE008858, 06EE010422, 06EE010432, 06EE010434, 06EE010442, 06EE010453, 06EE010454, 06EE010745, 06EE010747, 06EE010749, 06EE010758, 06EE010799, 06EE010804, 06EE010810, 06EE011357, 06EE011378, 06EE011379, 06FE000048, 06FE000050, 06FE000054, 06FE000055, 06FE000057, 06FE000985, 06FE001000, 06FE001012, 06FE001604, 06FE001612, 06FE001625, 06FE006654, 06FE006661, 06FE007243, 06FE008820, 06FE008829, 06FE008832, 06FE009212, 06FE010083.
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44035
For Additional Information ContactJanice 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
ActionThe recalling firm notified their consignees in a letter dated 6/26/06.
Quantity in Commerce36 wheelchairs
DistributionNationwide and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IOR
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