Z-0659-2013Class II

The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis...

Name: Z-0659-2013 The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis...
Creator: Zimmer, Inc.
Published: 2012-09-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-09-20 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis... on 2012-09-20. FDA classified it as Class II and gives the reason as "Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0659-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Posted: 2013-01-09
Terminated: 2014-04-23
Recalling firm: Zimmer GmbH
Product: The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer sent a "MEDICAL DEVICE CORRECTION" letter dated September 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Risk Manager Confirmation Form was attached for customers to complete and return. Questions and concerns should be addressed to Zimmer Spine Customer Service at 866-774-6368. When re-design is approved, Zimmer will remove and replace all affected devices.
Quantity in commerce: 170
Distribution: USA nationwide; Europe, Sweden
Product codes and lots: Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0659-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0659-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)