Device 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.
Z-0659-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 63559
- Status
- Terminated
- Classification
- Class II
- Quantity
- 170
- Official record key
device-enforcement:Z-0659-2013
Official wording
Reason: 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
Code information: Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,
Distribution pattern: USA nationwide; Europe, Sweden
Derived failure modes
-
Unknown
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