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U.S. Department of Health and Human Services

Class 3 Device Recall Pronto M51 Wheelchair

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 Class 3 Device Recall Pronto M51 Wheelchairsee related information
Date Initiated by FirmJune 14, 2006
Date PostedAugust 10, 2006
Recall Status1 Terminated 3 on August 22, 2007
Recall NumberZ-1400-06
Recall Event ID 35681
510(K)NumberK021680 
Product Classification wheelchair seat - Product Code ITI
ProductPronto M51 Wheelchair, component- seat
Code Information There is no code on the individual seat. Recall covers seats on wheelchairs distributed between 03/14/2006 and 04/07/2006.
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44035
For Additional Information ContactJanice Brownlee
440-329-6000
Manufacturer Reason
for Recall		Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.
FDA Determined
Cause 2		Other
ActionThe recalling firm sent a recall letter, dated 06/06 to consignees.
Quantity in Commerce853 units
DistributionNationwide.
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 = ITI
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