Z-1870-2008

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

Name: Z-1870-2008 Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for...
Creator: Medacta Usa Inc
Published: 2008-05-21
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2008-05-21 / Terminated / root cause: labeling and UDI

FDA source

Medacta Usa Inc began a recall of 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... on 2008-05-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1870-2008
Status: Terminated
Initiated: 2008-05-21
Posted: 2008-09-16
Terminated: 2012-04-30
Recalling firm: Medacta USA, Inc.
Product: 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.
Product code: FWX Table, Operating-Room, Mechanical
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.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 20 Units
Distribution: Nationwide to CA, CO, FL, ID, NV, TX & UT; Worldwide to: Belgium, France, Germany, Italy & Switzerland
Product codes and lots: All product of Model Number 01.15.10.0172 are subjectto this safety notification

Product code FWX

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)