Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers R

FDA device recall Z-0468-2007 · posted 2007-01-10 · Terminated

Recall details

Recalling firm

Ossur

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

ISH

Quantity affected

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.

Date initiated

2006-11-03

Date posted

2007-01-10

Date terminated

2008-05-28

Location

Reykjavik, Ireland