FDAJuly 7, 2016device

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 inferio...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

zimmer trabecular metal technologyzimmerzimmer trabecular

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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