Z-0659-2013 Class II Terminated
FDA device recall Z-0659-2013 was initiated by Zimmer, Inc. on Sep 20, 2012 and is designated Class II. 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… The recall status is terminated (terminated Apr 23, 2014). Affected quantity: 170.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 16, 2013
- Initiation Date
- Sep 20, 2012
- Termination Date
- Apr 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170
Product Description
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.
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
Distribution Pattern
USA nationwide; Europe, Sweden
Code Information
Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0659-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026