Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
The TM Ardis Interbody System implant is a convex Recalled by Zimmer Trabecular Metal Technology, Inc. Due to This field action is being initiated following the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Trabecular Metal Technology, Inc. directly.
Affected Products
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.
Quantity: 299 units; 200 brochures
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer Trabecular Metal Technology, Inc.
Zimmer Trabecular Metal Technology, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report