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Terminated

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

FDA Recall Z-1149-2007 · Posted 2007-08-07

Recalling FirmApplied Composite Technology
Recall StatusTerminated
Product CodeISH
Date Initiated2007-06-20
Date Terminated2008-06-05
Product Quantity97 units

Reason for Recall

Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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