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.
FDA Recall Z-1892-2017 · Posted None
Recalling FirmZimmer Trabecular Metal Technology, Inc.
Recall StatusTerminated
Product CodeMAX
Date Initiated2016-07-07
Date Terminated2017-05-03
Product Quantity299 units; 200 brochures
Reason for Recall
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.
Firm Action
Zimmer Biomet sent an Urgent Medical Device Correction Notice dated July 7, 2016, to all consignees on the list requiring them to destroy all literature and notify Zimmer Biomet of others who they have disseminated the material further. Retraining the sales force on the use of the TM Ardis. The details of the strategy are contained within the Draft Recall Strategy attached to the email transmitting this report. For further questions, please call (973) 576-0032.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.