Z-1892-2017Class III

The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the...

Name: Z-1892-2017 The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the...
Creator: Zimmer Trabecular Metal Technology, Inc.
Published: 2016-07-07
License: https://open.fda.gov/license/

Zimmer Trabecular Metal Technology, Inc. / initiated 2016-07-07 / Terminated

FDA source

Zimmer Trabecular Metal Technology, Inc. began a recall of 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... on 2016-07-07. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1892-2017
Classification: Class III
Status: Terminated
Initiated: 2016-07-07
Posted: 2017-05-10
Terminated: 2017-05-03
Recalling firm: Zimmer Trabecular Metal Technology, Inc.
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
FDA root cause: Unknown/Undetermined by 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.
Quantity in commerce: 299 units; 200 brochures
Distribution: Nationwide Distribution
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1892-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1892-2017	Class III	Terminated	Voluntary: Firm initiated	2017-05-10	2017-04-28

Product code MAX

K113561Class IITm Ardis Interbody System Tm Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology / cleared 2012-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)