Recall Z-0659-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Zimmer, Inc.
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
| Date | Jan 9, 2013 (initiated Sep 20, 2012) |
| Status | Terminated |
| 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 |
| 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 | 170 |
| Distribution | USA nationwide; Europe, Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113561 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION Zimmer Trabecular Metal Technology, May 29, 2012 |