| | Class 2 Recall
VS-1000 Senator |  |
| Date Posted |
August 07, 2007 |
| Recall Number |
Z-1149-2007 |
| Product |
VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT. |
| Code Information |
Serial numbers: 34333, 35808, 37033, 37035, 37087, 38464, 38703, 38704, 38805, 40518, 40528, 071189, 0711102, 0711191, 0713127, 0713131, 0713148, 0713462, 0713563, 0713992, 0716616, 0718748, 0719938, 0719939, 0719940, 0719941, 0719942, 0719957, 0719958, 0719959, 0719960, 0719989, 0719992, 0719994, 0719996, 0720596, 0722098, 0722117, 0722119, 0722120, 0722121, 0722122, 0722123, 0722124, 0722125, 0722138, 0722139, 0722143, 0722144, 0722145, 0723618, 0723619, 0723621, 0723623, 0723624, 0723728, 0723729, 0723730, 0723732, 0724103, 0724106, 0724110, 0724807, 0724809, 0724810, 0724811, 0724812, 0724813, 0724814, 0724815, 0724816, 0726588, 0726593, 0726594, 0726595, 0726597, 0726601, 0726602, 0726603, 0726608, 0726611, 0726612, 0726613, 0726614, 0726615, 0726617, 0726632, 0726633, 0726634, 0726635, 0726636, 0726637, 0726765, 0726766, 0726767, 0726777, 0726779.
|
Recalling Firm/
Manufacturer |
Applied Composite Technology
425 East 400 North
Gunnison, Utah 84634 |
| For Additional Information Contact |
Meghan Eilbeck
949-672-0032
|
Reason for
Recall |
Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.
|
| Action |
On 06/20 and 06/21/2007 all recipients of the affected Senators were notified by telephone. They were asked to return all suspect prostheses for replacement. Follow-up emails and fax letters (6/21/07) were also sent. |
| Quantity in Commerce |
97 units |
| Distribution |
Worldwide Distribution- USA including states of CA, CO, FL, IL, MI, MN, MS, NC, NY, OR, PA, SC, TN, TX, VA, WA. VA facilities in CA and MI. Foreign distribution to Australia, Canada, Germany, Russia, South Africa, South Korea, and UK. |
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