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U.S. Department of Health and Human Services

Class 2 Device Recall Kuschall K Junior Manual wheelchair

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  Class 2 Device Recall Kuschall K Junior Manual wheelchair see related information
Date Initiated by Firm June 15, 2009
Date Posted November 25, 2009
Recall Status1 Terminated 3 on November 21, 2011
Recall Number Z-0421-2010
Recall Event ID 52445
510(K)Number K982336  
Product Classification Mechanical wheelchair - Product Code IOR
Product Kuschall K Junior Manual wheelchair
Code Information Model Numbers: 0806281234, 0806893858, 0806135534, 0806161578, 0806237627, 0806268153, 0806268154, 0806309590, 0806315524, 0806351557, 0806568768, 0806591793. 0806670117, 0806724855, 0806731287, 0806773921, 0807007811, 0807019897, 0807062866, 0807110193
Recalling Firm/
Manufacturer
Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44035
For Additional Information Contact Carroll Martin
440-329-6356
Manufacturer Reason
for Recall
The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.).
FDA Determined
Cause 2
Device Design
Action The firm contacted their customers by telephone and then sent a recall notification letter to each customer on 6/15/2009. Questions are directed to email: Recalls@Invacare.com or phone: 800-333-6900.
Quantity in Commerce 20 Wheelchairs
Distribution Product was distributed to the following states: CA, CO, MN, NJ, OR, PA, TX & VA and one to 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.
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