Ossur Grjothals 5 Reykjavik Ireland Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Ossur Grjothals 5 Reykjavik Ireland
Lot Codes / Batch Numbers
Model numbers RFXS0002, RFXS0003
Products Sold
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)
Ossur Grjothals 5 Reykjavik Ireland is recalling Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absor due to Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compro. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026