FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1870-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-05-21
- Posted
- 2008-09-16
- Terminated
- 2012-04-30
- 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 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
- 20 Units
- Distribution
- Nationwide to CA, CO, FL, ID, NV, TX & UT; Worldwide to: Belgium, France, Germany, Italy & Switzerland
- Lot, serial or model codes
- All product of Model Number 01.15.10.0172 are subjectto this safety notification
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FWX
- Firm FEI
- 3006639916
- Firm city
- Camarillo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28