VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.
This recall has been terminated (originally issued August 7, 2007).
- Company
- Applied Composite Technology
- Recall Initiated
- June 20, 2007
- Posted
- August 7, 2007
- Terminated
- June 5, 2008
- Recall Number
- Z-1149-2007
- Quantity
- 97 units
- Firm Location
- North Gunnison, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.