Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positione

FDA device recall Z-1870-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Medacta Usa Inc

Reason for recall

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.

Action taken

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 clamps for the universal table as well as in the use of the safety straps. Customers have also been provided with a hang tag that reinforces the use of the safety straps when attaching the universal table. An additional copy of the notification will be provided to the sales representatives responsible for these hospitals. Included in these packets are instructions for the sales representatives to visit each hospital and provide hands-on training to the operating room personnel regarding proper attachment of the universal table, use of the clamps, and use of the straps. If you have questions, contact Medacta USA at 1-800-901-7836.

Root cause

Labeling design

Status

Terminated

Product code

FWX

Quantity affected

20 Units

Distribution

Nationwide to CA, CO, FL, ID, NV, TX & UT; Worldwide to: Belgium, France, Germany, Italy & Switzerland

Date initiated

2008-05-21

Date posted

2008-09-16

Date terminated

2012-04-30

Location

Camarillo, CA