Zimmer Trabecular Metal Technology, Inc. recalls The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior co…

Recall date

July 7, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1892-2017

FDA classification

Class III

Brand / firm

Zimmer Trabecular Metal Technology, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.