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U.S. Department of Health and Human Services

Class 2 Device Recall REFlex VSP Prosthetic foot

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  Class 2 Device Recall REFlex VSP Prosthetic foot see related information
Date Initiated by Firm November 03, 2006
Date Posted January 10, 2007
Recall Status1 Terminated 3 on May 28, 2008
Recall Number Z-0468-2007
Recall Event ID 36883
Product Classification Prosthetic foot - Product Code ISH
Product Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007
Code Information Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007. Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use. (sold between 25th of August and October 2006)
Recalling Firm/
Manufacturer		 Ossur
Grjothals 5
Reykjavik Ireland
For Additional Information Contact Dick Smith
517-629-8890 Ext. 104
Manufacturer Reason
for Recall		 Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot
FDA Determined
Cause 2		 Other
Action By letter on Nov 9, 2006. An initial letter was sent to all involved customers stating the invoice number, the purchase order number and the original shipping date. The problem is explained and the detailed exchange process is outlined. Contact information is included (ref. enclosure 2.1). At the same time as the mailing, all customers are being contacted proactively by a customer service representative.
Quantity in Commerce 138 worldwide (86 in US)
Distribution Nationwide in US plus Worldwide distribution in Canada, Austria, Switzerland, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Israel, Italy, Netherlands and Norway.
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.
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