Recall Z-1149-2007 ยท ISH Component, External, Limb, Ankle/Foot
Applied Composite Technology
VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.
| Date | Aug 7, 2007 (initiated Jun 20, 2007) |
| Status | Terminated |
| Reason | Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.