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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 col
Recalled May 10, 2017 · FDA recall Z-1892-2017 · Zimmer Trabecular Metal Technology
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. · FDA Class III
Units
299 units; 200 brochures
Sold at
Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Zimmer Trabecular Metal Technology, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →