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U.S. Department of Health and Human Services

Class 2 Device Recall VS1000 Senator

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  Class 2 Device Recall VS1000 Senator see related information
Date Initiated by Firm June 20, 2007
Date Posted August 07, 2007
Recall Status1 Terminated 3 on June 05, 2008
Recall Number Z-1149-2007
Recall Event ID 38289
Product Classification Prosthetic foot - Product Code ISH
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 UT 84634
For Additional Information Contact Meghan Eilbeck
949-672-0032
Manufacturer Reason
for Recall		 Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.
FDA Determined
Cause 2		 Other
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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