Z-1149-2007

VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite...

Name: Z-1149-2007 VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite...
Creator: Applied Composite Technology
Published: 2007-06-20
License: https://open.fda.gov/license/

PROTEOR USA, Gunnison / initiated 2007-06-20 / Terminated

FDA source

Applied Composite Technology began a recall of VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT on 2007-06-20. The reason FDA records is "Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1149-2007
Status: Terminated
Initiated: 2007-06-20
Posted: 2007-08-07
Terminated: 2008-06-05
Recalling firm: PROTEOR USA, Gunnison
Product: VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.
Product code: ISH Component, External, Limb, Ankle/Foot
Reason for recall: Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.
FDA root cause: 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.
Product codes and lots: 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.

Product code ISH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)