Z-0468-2007

Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber...

Name: Z-0468-2007 Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber...
Creator: Ossur
Published: 2006-11-03
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2006-11-03 / Terminated

FDA source

Ossur began a recall of Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007 on 2006-11-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0468-2007
Status: Terminated
Initiated: 2006-11-03
Posted: 2007-01-10
Terminated: 2008-05-28
Recalling firm: Ossur Iceland ehf.
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
Product code: ISH Component, External, Limb, Ankle/Foot
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 root cause: 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.
Product codes and lots: 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)

Product code ISH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)