Recall Z-1870-2008 ยท FWX Table, Operating-Room, Mechanical
Medacta Usa Inc
Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.
| Date | Sep 16, 2008 (initiated May 21, 2008) |
| Status | Terminated |
| Reason | Medacta is issuing this Recall because improper connection of the table clamping mechanism may result in the AMIS table becoming separated from the surgical table resulting in injury to the patient. |
| Root cause | Labeling design |
| Action | The Notification was sent via FedEx overnight on 05/27/2008 to the Director of Risk Management, Director of Biomedical, and Director of Operating Room at each institution with a table. The Safety Notification included: (1) Revised Instructions for Use that include (a) Improved instructions for the attachment of the clamps, and (b) Instructions for the use of new safety straps to provide a fail-safe attachment means. (2) A hang tag for labeling the devices. (3) A reply card indicating that the label has been attached to the table. Customers have been instructed in the proper adjustment of the |
| Quantity | 20 Units |
| Distribution | Nationwide to CA, CO, FL, ID, NV, TX & UT; Worldwide to: Belgium, France, Germany, Italy & Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.