| | Class 2 Recall
RE-Flex VSP Prosthetic foot |  |
| Date Posted |
January 10, 2007 |
| Recall Number |
Z-0468-2007 |
| 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 |
| For Additional Information Contact |
Dick Smith
517-629-8890 Ext. 104
|
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 |
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. |
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