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U.S. Department of Health and Human Services

Class 2 Device Recall Tracer IV wheelchairs

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 Class 2 Device Recall Tracer IV wheelchairssee related information
Date Initiated by FirmApril 16, 2012
Date PostedJanuary 08, 2014
Recall Status1 Terminated 3 on January 10, 2014
Recall NumberZ-0634-2014
Recall Event ID 67134
Product Classification Wheelchair, mechanical - Product Code IOR
ProductTracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
Code Information Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.
FEI Number 3002889431
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
Elyria OH 44035-4190
For Additional Information ContactSwasita Saigal
440-329-6875
Manufacturer Reason
for Recall		The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
FDA Determined
Cause 2		Component design/selection
ActionThe firm, Invacare, sent a memo dated December 4, 2013 to their customer. The memo described the product, problem, and actions to be taken . On February 8, 2012 representatives from the recalling firm visited the customer to investigate the complaint. The wheelchairs were returned and destroyed. If you have any question, please call 440-329-6875 or email: ssaigal@invacare.com.
Quantity in Commerce227 Wheelchairs
DistributionUS Distribution: Michigan only.
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.
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